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Date Job Title Job Level Location
3/6/21 Associate Scientist/Scientist, Hematology Reverse Translation Individual contributor South San Francisco, California

We seek a highly talented and motivated Associate Scientist to join Genentech’s cutting-edge Hematology Reverse Translation effort.

The candidate will be a lab-based member of a cross-functional team of biomarker scientists, discovery scientists, pathologists, computational scientists, and clinical researchers working together to translate clinical trial findings into the next generation of therapeutic strategies. The candidate will generate novel biological insights from clinical trial samples to identify targets and combination strategies that will shape new discovery and development programs. The candidate will grow over time into a leader in mechanisms of response and resistance to immune engaging therapies and translational medicine in hematology. Genentech has an extensive hematology pipeline and a wealth of research and clinical expertise in heme malignancies including multiple T-cell engaging bispecific antibodies in early and late-stage development. The candidate will have unparalleled infrastructure and research support at their disposal. The successful candidate is expected to work seamlessly as part of a multifunctional team, have excellent oral and written communication skills, participate and contribute to team meetings, publish in high quality scientific, technical or medical journals and present at internal and external meetings.

Role:

  • Design, conduct, and interpret experiments to identify, validate, and characterize mechanisms of response and resistance to T-cell engaging therapies with emphasis on tumor microenvironment interactions and functional interplay of different immune cell populations
  • Responsible for integrating various biomarker datasets, preclinical and clinical findings to generate hypotheses that will lead to rational combinations and identification of novel therapeutic avenues
  • Employ and develop cutting-edge experimental approaches to enable discovery of emerging mechanisms of action or resistance and in-depth disease biology understanding
  • Analyze large, multi-omic datasets, including single cell datasets and large-scale clinical trial data
  • Participate in and contribute to team, department, and leadership meetings and collaborate with scientists across different departments at Genentech and externally
  • Publish scientific and methodological results in high quality journals

Who you are:

  • PhD degree in a relevant scientific field (e.g. immunology, molecular biology, cancer genetics, cancer biology, molecular oncology, signaling) with 0-5 years of postdoctoral experience
  • Experience in hematology or translational research with preference for immunology training and ability to perform high quality functional assays
  • Experience with single cell methodologies or experience with 3D and ex vivo tissue modeling is highly desirable
  • Ability to work with large, multiomic datasets including single cell datasets using statistical software packages such as R is preferred but not required
  • Demonstrated record of cutting-edge research as evidenced by first authored publications in top tier journals
  • Be able to distill complex issues and clearly articulate solutions
  • Ability to collaborate, lead, influence and motivate others
  • Ability to demonstrate effectiveness and growth

What to expect from us:

  • A highly collaborative and dynamic research environment where we aim to translate our understanding of hematologic malignancies and immunology and develop personalized therapies and diagnostics to transform clinical practice to benefit patient health.
  • Opportunity for cutting-edge research leveraging clinical data sets and samples and state of the art technologies and research tools
  • Train as a Development Scientist in a leading Oncology company
  • Participation in seminar series featuring academic and industry scientists and opportunities to publish in top-tier journals
  • Campus-like lifestyle with a healthy work-life balance

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Roche is an equal opportunity employer.

3/6/21 Senior Scientific Researcher - Ophthalmology Individual contributor South San Francisco, California

We are seeking a highly motivated Senior Scientific Researcher to join the OMNI Biomarker group within Development Sciences. Our group is responsible for developing and implementing biomarkers for programs in Ophthalmology. The successful candidate will join our team and work to identify and profile biomarkers in preclinical models and implement diagnostic and pharmacodynamic assays in clinical trials of novel therapeutics.

Responsibilities:

  • Discover and evaluate biomarkers in different cell systems and in preclinical models
  • Develop and optimize biomarker assays
  • Implement biomarker assays in clinical trials
  • Evaluate new technologies to support clinical biomarker assay development

Who You Are

Requirements:

  • BSc. MSc. With >6-9 years of related work experience in biotech or an academic research environment
  • Proactive and independent researcher
  • Substantial experience in immunoassays, biochemistry, and cell biology techniques
  • Strong technical skills in whole blood, cell based assays and tissue processing
  • Experience in developing and implementing clinical biomarker assays a plus
  • Able to learn new methodologies quickly and efficiently and to work in different disease areas
  • Able to design, execute, and troubleshoot experiments independently
  • Able to analyze and interpret results including analysis of large datasets using MS Excel, Spotfire, R and other statistical tools
  • Excellent organizational and time management skills
  • Skillful at interpreting and clearly communicating results
  • Ophthalmology experience a plus.

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3/5/21 Therapeutic Area Manager (TAM), Ophthalmology – DC-Baltimore-VA Ecosystems Individual contributor Maryland

Therapeutic Area Manager (TAM), Ophthalmology – DC-Baltimore-VA Ecosystems

Territory: DC, Baltimore, Hagerstown, Fredrick, Northern VA, Winchester, Richmond, Charlottesville, Norfolk ((candidate will live in territory ideally in DC, Baltimore or Northern VA)

Position Overview From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver even better health outcomes for patients while lowering overall healthcare costs.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care. The role covers the Central-and-North Florida geographies.

The Ophthalmology TAM is empowered to own components of the business within their respective ecosystems and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the business strategy. The TAM will represent all relevant products (LUCENTIS today and upon FDA approval, PDS and faricimab) and indications.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting insights and trends for their respective ecosystems and being a conduit between an ecosystem, the Ophthalmology Squad and marketing to support the national strategy at a local level. The TAM will represent Genentech Ophthalmology products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

There are two levels of Therapeutic Area Managers. The difference is based on the scope, complexity and criticality to the ecosystem business as well as differences in expertise required to execute responsibilities.

Key Accountabilities

1. Serve as one of primary points of contact for ophthalmology customers in the ecosystem. Address and identify opportunities for pulling through ecosystem and Ophthalmology squad strategies at the point-of-care

2. Apply strong understanding of the specific needs of healthcare practitioners and

mobilizes ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care

3. Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals

4. Deliver education to HCPs regarding product information, appropriate use, and dosing

and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate

5. Address product acquisition (contract awareness, etc.), and address supply matters through coordination of distribution issues, and managing spoilage and returns

6. Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to Ophthalmology HD and FRM Ophthalmology as appropriate

7. Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact

8. Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials

9. Lead, act and live our Operating Principles in all aspects of work

Qualifications

● Scientific or clinical degree, Bachelor’s degree level at minimum

● Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required

● 4 or more years’ experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment

● Knowledge and experience with Ophthalmology and/or Retina is a plus

● Biologics, Injectable and/or buy & bill experience is preferred

● Ability to work in an ambiguous environment undergoing transformation is a strong plus

● Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities

● Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals

● Self-starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem

● Ability to assimilate and communicate complex clinical and product information

● Knowledge of and ability to successfully address operational issues in the delivery of healthcare products to patients, such as reimbursement and supply

● Understanding of external laws, codes and company policies that apply to the healthcare industry

Operating Principles

I put the patient first, always. 

I am obsessed with meeting customer needs. 

I act on behalf of the whole company, not just my team. 

I am inclusive.  

I build a culture of trust. 

I have a growth mindset. 

I act with urgency. 

I am accountable. 

I radically simplify and prioritize for impact. 

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

It is required the candidate live within the DC-Baltimore or VA Ecosystems. 

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business. Colorado applicants are not eligible

Candidate must live within the DC-Baltimore or VA Ecosystems.   Although individual contributors in Ophtha may overlap a few ecosystems, this position will mostly work DC, Maryland and Virginia.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.   Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society.  We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide  an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

The next step is yours. To apply today, click on the "Apply for this job" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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3/5/21 Therapeutic Area Manager (TAM) - Ophthalmology, Western WA/ AK/ MT Individual contributor Washington

Therapeutic Area Manager (TAM), Ophthalmology

Position covers: Western Washington, Alaska, and Montana. Candidate will need to live within the geography

Position Overview From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver even better health outcomes for patients while lowering overall healthcare costs.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care.

The TAM Ophtha is empowered to own components of the business within their respective ecosystems and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the business strategy. The TAM will represent all relevant products (LUCENTIS today and upon FDA approval, PDS and faricimab) and indications.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting insights and trends for their respective ecosystems and being a conduit between an ecosystem, the Ophtha Squad and marketing to support the national strategy at a local level. The TAM will represent Genentech Ophthalmology products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

Key Accountabilities

1. Serve as one of primary points of contact for ophthalmology customers in the ecosystem. Address and identify opportunities for pulling through ecosystem and Ophtha squad strategies at the point-of-care

2. Apply strong understanding of the specific needs of healthcare practitioners and

mobilizes ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care

3. Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals

4. Deliver education to HCPs regarding product information, appropriate use, and dosing and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate

5. Address product acquisition (contract awareness, etc), and address supply matters through coordination of distribution issues, and managing spoilage and returns

6. Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to Ophtha HD and FRM Ophtha as appropriate

7. Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact

8. Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials

9. Lead, act and live our Operating Principles in all aspects of work

Qualifications

● Scientific or clinical degree, Bachelor’s degree level at minimum

● Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required

● 4 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment

● Knowledge and experience with Ophthalmology and/or Retina is a plus

● Biologics, Injectable and/or buy & bill experience is preferred

● Ability to work in an ambiguous environment undergoing transformation is a strong plus

● Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities

● Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals

● Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem

● Ability to assimilate and communicate complex clinical and product information

● Knowledge of and ability to successfully address operational issues in the delivery of healthcare products to patients, such as reimbursement and supply

● Understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech Operating Principles

I put the patient first, always.

I am obsessed with meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive. 

I build a culture of trust.

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify and prioritize for impact.

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

Candidates must live within the ecosystem.

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

3/5/21 Therapeutic Area Manager- Ophthalmology, Kansas/ Western MO Ecosystem Individual contributor Missouri

Therapeutic Area Manager (TAM), Ophthalmology

Position Overview From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver even better health outcomes for patients while lowering overall healthcare costs.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care.

The TAM Ophtha is empowered to own components of the business within their respective ecosystems and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the business strategy. The TAM will represent all relevant products (LUCENTIS today and upon FDA approval, PDS and faricimab) and indications.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting insights and trends for their respective ecosystems and being a conduit between an ecosystem, the Ophtha Squad and marketing to support the national strategy at a local level. The TAM will represent Genentech Ophthalmology products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

Key Accountabilities

1. Serve as one of primary points of contact for ophthalmology customers in the ecosystem. Address and identify opportunities for pulling through ecosystem and Ophtha squad strategies at the point-of-care

2. Apply strong understanding of the specific needs of healthcare practitioners and

mobilizes ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care

3. Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals

4. Deliver education to HCPs regarding product information, appropriate use, and dosing

and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate

5. Address product acquisition (contract awareness, etc), and address supply matters through coordination of distribution issues, and managing spoilage and returns

6. Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to Ophtha HD and FRM Ophtha as appropriate

7. Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact

8. Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials

9. Lead, act and live our Operating Principles in all aspects of work

Qualifications

● Scientific or clinical degree, Bachelor’s degree level at minimum required

● Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required

● 4 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment is required

● Knowledge and experience with Ophthalmology and/or Retina is strongly preferred

● Biologics, Injectable and/or buy & bill experience is strongly preferred

● Ability to work in an ambiguous environment undergoing transformation is a strong plus

● Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities

● Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals

● Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem

● Ability to assimilate and communicate complex clinical and product information

● Knowledge of and ability to successfully address operational issues in the delivery of healthcare products to patients, such as reimbursement and supply

● Understanding of external laws, codes and company policies that apply to the healthcare industry

Operating Principles

I put the patient first, always.

I am obsessed with meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive. 

I build a culture of trust.

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify and prioritize for impact.

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

Candidates must live within the ecosystem.

*Colorado applicants are not eligible at this time

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

3/5/21 Group Director, Early Development Safety, gRED Oncology Manager with direct reports South San Francisco, California

The Group Director (GD) leads and directs a global group of Safety Strategy Leaders (SSLs), within their assigned area (gRED Oncology), to ensure they provide strategic direction and continuous safety-related support for their assigned molecules/medicines. The SSL role holders are ‘on point’ to lead and shape safety strategies and plans for their assigned molecules/medicines, and ensure those strategies/plans can be executed upon effectively, in close partnership with wider stakeholders (e.g. Portfolio Clinical Safety (PCS)). The GD is accountable for overseeing and guiding the performance of their assigned SSLs, to ensure they consistently deliver in line with relevant business strategies, required behaviours, quality requirements, defined processes, and to agreed customer requirements. Additionally the GD is personally responsible for supporting and shaping safety-related activities and stakeholder interactions that are routinely required at the disease area or franchise levels (i.e. activities that span across multiple molecules/programs, and may involve routinely collaborating with Early Clinical Development Heads, Clinical TA Heads, DRC’s and the relevant teams/bodies that operate and make decisions at that level). The GD will ensure that they, and their assigned SSLs, work in close collaboration with partners across PDS, and more widely, to support the coordinated delivery of various molecule- or disease area-focused safety activities. The GD will also ensure relevant PDS LT-level Heads (e.g. EDS Global Head) remain informed of their team’s delivery priorities, performance and they share information on relevant safety topics/issues, as appropriate.

The GD collaborates with PCS GD counterparts, to ensure delivery performance oversight and quality of outputs; seeking to address any issues holistically so that their shared customers receive a seamless service. Across the EDS and LMMS functions, the GD’s also coordinate the transition of knowledge for those molecule assets that are transitioning through development: They ensure that a robust and independent safety position is established/maintained/shared for the assets supported across their respective teams. The GD provides leadership, management, mentoring, coaching and professional development support for their assigned SSLs; ensuring they remain equipped to deliver value to their respective cross-functional molecule/product teams. They ensure they maintain the necessary skills (both technical and behavioural) and can incorporate new/innovative approaches where relevant. Across EDS, LMMS & PCS, the collective GD’s ensure there is effective capacity planning, performance oversight and talent development planning/support: Ensuring priorities across all SSL-led programs, PV deliverables and other safety-related scientific outputs, can be delivered by their assigned scientific/HCP experts. Overall, the GD contributes to a holistic approach to the delivery of scientific safety value across teams.

Primary Responsibilities and Accountabilities:

Leadership Values and Behaviours

  • The GD role-models the Roche Values and Leadership Commitments.
  • Sets direction in terms of remit, emphasis, style, behaviors and culture for the assigned SSLs.
  • Drives and embeds the agreed organizational models, the necessary mindsets: Promoting new ways of working and empowering SSLs to act as the visible safety leader for their assigned area.
  • Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions.
  • Anticipates potential issues, risks, and opportunities, and acts as needed.
  • Willing to challenge embedded behaviors/mindsets, to bring new and agile approaches to ways of working, and to improve quality and efficiency.
  • Supports the entire PDS organization, other peers, and direct reports so that they can take appropriate accountability for their practices and actions.

Scientific Delivery & Business Unit Oversight

  • Accountable for ensuring that, across gRED Oncology, all component molecules/programs have dedicated safety strategies and plans in place to ensure that clinical risks are anticipated, detected, characterised, communicated and managed, in line with wider business plans and strategies. Ensuring these strategies align with DA/molecule level plans (e.g., DAS, TPP, CDP, etc.) and that they position PDS to deliver effective program- and study-level safety design and decision-making influence. Overseeing implementation, in partnership with the PCS Group Directors, to execute upon the safety strategies and plans.
  • Support the assigned team to build relationships and grow their influence with relevant stakeholders to ensure scientific delivery impact, and the delivery of all required safety outputs is achieved in line with the organisational priorities/plans and to agreed customer requirements.
  • In the context of ensuring PDS functional input to relevant decisions; ensure that SSLs are equipped to participate in relevant safety related decision making activities (e.g. in partnership with cross-functional development teams). Additionally, acting as a key contributor (e.g. as a reviewer, or member of decision making bodies or internal committees) for relevant safety decision making activities that are required at the disease area or franchise levels (e.g. DRC meetings).
  • In line with relevant process requirements and any relevant responsibilities defined in role descriptors: Act as an expert reviewer for relevant safety-related documents that have been prepared by the relevant SSLs and supporting teams (e.g. safety strategies and plans; safety content of protocols; DSRs; clinical study reports; Investigator's Brochure (IB); ISMPs; relevant safety communications; and safety-related scientific publications), as appropriate.
  • Collaborate and partner with PCS GD’s to ensure co-development, implementation and monitoring of the effectiveness of risk assessment or risk mitigation approaches (e.g. guided safety questionnaires) and the overall execution of molecule/product-related safety support.
  • Accountable for the implementation of effective molecule safety strategies across the assigned teams of SSLs; ensuring the success of safety risk minimization/mitigation plans are monitored; that safety-related aspects of the Medical Value Narrative are delivered and maintained; and that approaches that aim to ‘personalise safety' are explored. 
  • Accountable for ensuring that the molecule safety strategies devised by their teams adopt relevant new strategic approaches/solutions (e.g. utilisation of novel approaches developed via the Safety Strategy program; or implement continuous improvements to ways of working developed in collaboration with PVSD; or support the adoption of new PHC-related innovations, etc).
  • Where requested by their Global Head, may be required to represent their function at relevant governance or decision bodies (e.g. GVP Council, DSC, DRC meetings, TA Advisory Meetings) and/or participate on relevant cross-functional programs (e.g. Safety Strategy teams; PD Leader meetings & TA initiatives that could impact the portfolio/safety function) 
  • Where requested by relevant senior leaders, the jobholder may be required to represent PDS or Roche at external meetings with regulatory authorities and third parties such as potential licensing or co-development partners, etc. Furthermore, the job holder may be required to coach and support members of their teams when they are assigned to perform these types of activity.

Stakeholder Management and Relationship Building

  • Working in close partnership with scientific delivery stakeholders (i.e. across EDS, LMMS, PCS) to ensure a holistic approach to delivering valued scientific outputs/services to the full range of PDS customers. Striving to ensure that the experts participating across the different functional teams are coordinated to deliver effectively and to support each other in achieving their aims. Also ensuring that the medium-to-long term approach to talent acquisition and development is planned and coordinated in close collaboration to ensure the scientific talent pipeline across PDS is equipped to deliver on the current and future safety-related needs of customers.
  • Builds strong partnerships with all other PDS/PD functions, growing and sustaining rapport and trust with the peer Group Directors and other stakeholders.
  • Collaborates with internal Roche stakeholders to ensure that they, and their assigned team, are delivering upon relevant molecule, disease and portfolio level strategies and shared priorities across the wider Roche organisation. Seeking feedback from across their respective customer groups (e.g. REDs, Clinical Development, Medical Affairs, Affiliates, EU QPPV, etc) to ensure that the influence and impact of their teams and their scientific deliverables are continually adding value and are supporting the delivery of the PDS strategy and value propositions.

People leadership and Line Management

  • Leading a global team of scientists and healthcare professionals performing SSL roles.
  • Co-creating, implementing and role modelling the vision/mission for the relevant sub-functional unit, and its contribution to the wider Roche Safety Strategy. Helping to shape how the organization, its people, processes and business practices can sustain and improve how PDS delivers upon its value propositions.  Ensuring the sub-function is performing in line with strategic objectives, agreed priorities and delivery requirements.
  • Ensure the implementation and delivery of a “high performance team culture”, where performance of staff is actively managed and supported (e.g. via coaching, training and leadership development) and their success and impact in delivering to varied customer requirements is actively assessed.
  • Working in close collaboration with GD peers across EDS, LMMS and PCS to ensure that current and future talent acquisition, development and deployment requirements are anticipated, planned for and met. Taking shared responsibility for the development of a pipeline of scientific talent that is able to support the shared activities performed across the scientific functions.
  • Comply with all governing employment laws, regulations and company HR policies and procedures, that are relevant to the locations where PCS operates

Education, Experience, Skills, Knowledge:

  • Minimum Qualifications: Qualified healthcare professional or Life Sciences graduate.
  • Preferred Qualifications: Candidates would typically be either healthcare professionals (e.g. physician/MD or PharmD), or scientists with relevant postgraduate scientific qualifications (e.g. Ph.D. or MSc in a relevant discipline such as epidemiology, pharmacovigilance, toxicology, clinical pharmacology, or Public Health); and all candidates would typically have considerable experience in clinical pharmaceutical development, clinical safety and/or clinical practice.
  • Candidates will typically possess more than 10 years of experience within a biopharmaceutical or clinical research organization environment and are likely to have considerable experience in safety-related aspects of clinical drug development, pharmacovigilance and/or medical affairs.
  • The ability to demonstrate a broad understanding of both pre- and post-approval drug development, and bring a broad knowledge of the scientific aspects of safety, PV and clinical/patient risk management (e.g., via demonstrable understanding of the application of GVP, GCP & CTR requirements) are essential.
  • Proven ability to understand, manage and routinely take decisions concerning safety issues, often in situations of ambiguity. Ideally, candidates will have experience in leading or participating in safety, benefit-risk, issue management and clinical risk management activities in a bio-pharmaceutical or healthcare organization. Past experience of operating in an SSL-type role would be useful.
  • Demonstrable people leadership skills would be strongly preferred. An understanding of the key factors involved in supporting talent and skills development (e.g. provision of effective coaching and talent development approaches for experienced professionals) would be highly advantageous.
  • Strong technical and strategic thinking, combined with the ability to devise, communicate and implement strategies at a product, matrix or organisational level would be an advantage.
  • Proven success in creating and sustaining strong relationships with internal partners across an organization, to foster positive partnerships. Strong influencing, negotiation and conflict management skills. Ability to influence with and without authority.
  • Where the jobholder is medically qualified, they may be required to perform specific duties that require specific medical qualifications/certifications (e.g. performing formal medical approver/signatory roles for safety documents). Any specific levels of qualification, certification or clinical experience that are considered mandatory to perform such roles, will be outlined separately in relevant PDS Role Descriptors. Where the job holder does not have the relevant background to perform such roles, these roles will instead be performed by other suitably qualified individuals within PDS, possibly from within the GD’s own team).

Travel Requirement:

  • Available to travel internationally up to 20% of the time

#LI-LM1

3/5/21 Global Studies Manager Individual contributor South San Francisco, California

At Roche/Genentech Pharma Product Development Operations we are determined to transform drug development and deliver novel medicines with outstanding benefit to patients at lower costs for the society. We want you to join us on this quest and be part of a highly passionate, global and collaborative team who takes pride and energy from challenging the status quo and finding fit for purpose solutions while executing our clinical trials with excellence. Bringing better lives to patients is our core aspiration and is at the heart of each of us while introducing innovation, fostering creativity and being part of high performing teams.

YOUR FOCUS You will be focused on molecules within one of our exciting therapeutic areas in Oncology or I2ON, having the opportunity to experience our multiple areas over time

YOUR TEAM You will report to a Global Studies Leader You will be recognized as a leader and work autonomously in a cross functional, global team

WHAT YOU WILL DO As a Global Studies Manager (GSM) at Roche/Genentech, you will lead or contribute to one or more cross-functional global working groups, expert squads, and global Study Teams, which deliver all operational aspects of one or more studies through all phases and stages. You will:

  • DRIVE OPERATIONAL EXCELLENCE By developing operational plans, creating and managing clinical study budget and overseeing the consistency of operations
  • LEAD AND INFLUENCE By establishing yourself as a leader within the team, being recognized as a thought leader who inspires others to perform at their best and learn from best practices. You’ll be shaping our capabilities and evolving your role overtime
  • PLAN DEMAND AND SUPPLY By overseeing the resource management, forecast and maintenance of supplies needed to ensure sites have the necessary supplies to run clinical studies
  • MANAGE VENDORS AND STAKEHOLDERS By managing relationships with vendors and cross-functional stakeholders. Oversee performance of vendors and third-party providers
  • MANAGE RISK AND COMPLIANCE By developing site monitoring and risk mitigation strategies and ensuring your team adheres to all appropriate standards, including ICH/GCP and other regulations
  • PROVIDE COUNTRY OVERSIGHT By leading feasibility assessments to ensure countries and sites are selected for participation in trials. Provide guidance to country operational reps during trials

HOW YOU WILL DO IT You will succeed as a Global Studies Manager by leading, collaborating, and relaying your expertise to cross-functional partners. You will:

• Apply your good knowledge of drug development process and respective regulations, including ICH and GCP guidelines

 • Apply your organizing and problem-solving skills to plan and run efficient operational aspects of a study

• Motivate others to deliver against commitments, including leadership of global teams across diverse cultures and time zones, embracing diversity and creating a culture of inclusion to ensure successful collaboration

• Demonstrate agility and ability to perform in a highly fast-paced, matrix environment where cross-team collaboration is crucial

• Leverage excellent verbal and written communication skills to motivate your team, negotiate with peers and partners and influence across stakeholders

• Advocate for what you and your team need to succeed

• Model Roche’s values in everything you do

WHO YOU ARE You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, rigorous and entrepreneurial spirit. You…

• Have a growth mindset and are excited about learning through experience

• Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments

• Have a minimum 3 years of relevant experience (clinical trial management is a plus)

• Hold a university degree or equivalent years of experience, preferred focus in life sciences

• A self-starter who finds passion in achieving successful outcomes by leading, directing and inspiring peers

• Want to make a difference and find excitement in innovating practices, products and processes • Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines

At Roche/Genentech, we believe our people are Key to our success in bringing novel medicines to patients and we are fully dedicated to being a great place to work and to provide the services, tools and the environment where everybody feels empowered, trusted and is enabled to uncover his/her true potential. Come join us and help build a diverse and inclusive organization where patient centricity and patient access is a priority.

3/5/21 Senior Scientific Researcher, Viral Vector Core Lab Individual contributor South San Francisco, California

We are seeking a Senior Scientific Researcher to join the Viral Vector Core Lab and contribute to our Translational Genomics efforts. Translational Genomics spans the interface of human genetics, functional genomics, molecular biology, cellular and tissue profiling, disease model engineering, and advanced computational methodology. This group works closely with our disease area scientists to identify new therapeutic hypotheses and advance transformative medicines.

The SSR will work in a fast-evolving and collaborative environment to advance viral vector (Lentivirus, adeno-associated virus, others) technologies and applications in both basic and pre-clinical research.  She/he will work independently to design, produce, and apply research materials that facilitate cutting-edge functional genomic screens, in vivo/somatic genome editing and cell/gene therapy programs. In addition, she/he will provide biosafety guidance and hands-on support for collaborator-driven efforts that span the entirety of Genentech’s research division.

Responsibilities

  • Responsible for virus production, purification, titration and QC.   

  • Responsible for designing, developing and optimizing viral vectors to deliver genetic materials in vitro and in vivo for therapeutic target discovery/validation and animal disease model engineering.

  • Collaborate with  research labs on the application of viral vectors and flow cytometer support. 

  • Assist in the maintenance of core lab facilities. 

  • Contribute to publications in high quality scientific journals and will have the opportunity to present through presentations at key internal and external meetings. 

 

Qualifications

  • The candidate must have a Ph.D. in Molecular Biology, Biochemistry, Genetics, Virology, Cell/Gene Therapy, Cancer Biology, Immunology, Neuroscience, or a related discipline. Post-doctoral or equivalent experience is desirable. 

  • Highly motivated, can lead technology development independently. 

  • Must have experience with one or more of the following areas: 

    • Engineering/Handling/Application of lentivirus, retrovirus, adenovirus, AAV, or other viral vector technologies.

    • CRISPR-Cas9, RNAi, ORF, and other technologies for gene modification/manipulation  in vitro or in vivo

    • Animal handling/surgeries/procedures, animal tissue processing and analysis

  • Experience with Next-Generation Sequencing (NGS), biostatistics, and/or basic bioinformatics is desirable.

  • Excellent interpersonal skills with demonstrated ability to work within a dynamic, collaborative research environment.

  • Excellent oral and written presentation skills.

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3/5/21 Scientific Researcher/Senior Scientific Researcher, Translational Immunology Individual contributor South San Francisco, California

The ocular group in Translational Immunology Department is seeking a motivated, interactive and flexible Senior Scientific Researcher to perform in vivo animal studies and in vitro characterization of preclinical endpoints. The successful candidate will be responsible for developing animal models of ocular diseases such as Glaucoma and AMD, and will use complementary approaches to assess retinal structure and function. This individual is expected to work effectively in a highly collaborative team setting to evaluate therapeutic candidates for blinding retinal diseases.

Responsibilities:

With a solid in vivo experience and rodent handling, the successful candidate will be in charge of experimental design and execution. In addition to ocular model induction, the candidate will perform intravitreal and subretinal injections and use in vivo multimodal imaging techniques (OCT, fundus, angiography). Retinal function will be assessed by electroretinography (ERG, pERG, VEP) and behavioral testing. Specific responsibilities will include ocular tissue collection, microdissection and processing for immunohistochemistry, cellular and molecular biology approaches. This individual will be responsible for data analysis, report generation and   communication.

Requirements:

The successful applicant will have a MS (Scientific Researcher) or PhD (Senior Scientific Researcher) in neuroscience, immunology, cell biology, or related field, preferably with a background in retina cell biology; 2+ years experience in academic or industry laboratory setting. Those familiar with techniques including ocular injections,  microdissection and electrophysiology will be given precedence. Good oral/written communication skills, problem-solving, flexibility, and the ability to integrate detailed analysis into a larger disease-oriented context will be expected.

Roche is an equal opportunity employer.

3/5/21 Senior Scientific Researcher, Protein Biochemist, Peptide Discovery Individual contributor South San Francisco, California

We’re looking for an experienced protein biochemist, chemist, or chemical biologist to join our group within the Department of Early Discovery Biochemistry. The group utilizes multidisciplinary tools for target validation across different therapeutic areas including oncology, immunology, and ophthalmology. Recent efforts focus on modulating protein-protein interactions and the study of cell-penetrating peptides. The successful candidate will be responsible for discovering and producing proteins and peptides of therapeutic interest. Additionally, the researcher will characterize such molecules by standard analytical methods and assess their functional mechanisms using biochemical, biophysical, and cell-based assays. This is a basic research position that requires critical thinking, flexibility, multitasking, and the ability to learn new techniques.

Requirements

  • Ph.D. in biochemistry, chemistry, chemical biology, or a related discipline working extensively with proteins and/or peptides

  • Experience in:

    • protein expression and purification (affinity, ion exchange, size exclusion, and/or HPLC)

    • standard protein and peptide analytical methods (LCMS, SDS-PAGE, western)

    • biochemical (e.g. ELISA), biophysical (e.g. SPR/BLI), and cell-based assays

    • construct design and molecular biology

  • Can work both independently and collaboratively; is highly team-oriented

  • Has strong analytical, organizational, and communication skills

  • Sustained record of productivity as evidenced by publications in top-tier journals or patent inventorships

Preferred Qualities

  • Experience with library display technologies (phage, mRNA, yeast)

  • Previous experience with conjugation reactions or other chemical modifications of proteins

  • A deep understanding of the chemical and molecular principles that drive protein interactions, as well as the ability to model these interactions using appropriate software

  • Relevant postdoctoral or industry experience

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3/5/21 Site Head, Hillsboro Individualized Therapies (HIT) Executive (Director/VP) Hillsboro, Oregon

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.  We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.

Summary:

The Site Head, Hillsboro Individualized Therapies (HIT) is accountable for starting and heading up Roche's cutting edge personalized medicine production site to realize Roche's initiative for  Individualized Neoantigen Specific Therapy as well as Cell Therapy, including the USD $250million facility build/scale up. To achieve this objective and blaze a new trail to change the future of medicine and treatment of cancer, Roche Pharma/Genentech has created this position which is the rarest of opportunities as it combines and enjoys the benefits of both an internal start-up with speed and agility, while working with, and in, an industry-leading healthcare company with an iconic brand. The Vice President and Site Head of Hillsboro Individualized Therapies (HIT) will report to the Global Head, Pharma Drug Product Manufacturing, Sven Hauptmann.

This position will lead the facility start-up into clinical supply and ultimately commercial manufacturing. This role will require excellent collaboration and influencing skills and the ability to lead diverse, cross-functional teams in the successful completion of projects. The position will over time evolve into the accountability for operational management of all GMP operations.

 

Key Responsibilities

 

Developing and implementing an operational plan including staffing and operating model for delivering clinical and ultimately commercial supply to health care providers within promised lead times. 

  • Working collaboratively and developing relationships with all internal stakeholders, as well as external partners. Collaborating effectively with partner groups including Research, Development, Quality, Engineering, Regulatory, Supply Chain and Manufacturing. 

  • Defining and developing new processes, procedures, and techniques, and incorporating them into operational practice. 

  • Representing Roche Pharmaceutical’s and Roche Group’s interests with important external stakeholders as appropriate, e.g. government and regulatory officials, health authorities, industry associations, media, key opinion leaders, physicians, patients, and advocates.

  • Continuing to strengthen the image of Roche as the leader within the healthcare industry.

  • Attracting, developing and retaining a diverse high performing talent pool.

  • Establishing an efficient/effective organizational structure with clearly defined roles and responsibilities.

  • Building individual and organizational capability through effective implementation of Roche programs and people practices.

  • Ensuring succession planning is completed per the PTG process i.e. identify key positions, review regularly having potential succession candidates identified and job profiles up to date.

 

The Candidate Profile:

 

The ideal candidate will be a smart, well-rounded, energetic, and a charismatic leader. Necessary for success are strategic agility, technical and business acumen and expertise, an unrelenting focus on achieving results and strong organizational, change management and transformation, and communication skills. This individual must be able to influence other functions in a collaborative manner to achieve the required outcomes.

 

Necessary Experience/Skills:

  • Bachelor’s degree preferably in science, engineering, biotechnology or a related discipline. An advanced degree is highly preferred.

  • 15+ years of experience in leading cross-functional organizations in pharma tech operations in progressively responsible roles.

  • Prior leadership of GMP manufacturing operations and start –up, preferably in mRNA or CAR-T manufacturing.

  • Proven strategic agility and the ability to analyze complex issues and opportunities, exercise sound judgment, make tough decisions and take calculated risks with the future in mind.

  • Demonstrates sound judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates, influences and escalates issues and decisions as needed.

  • Results focused leader with the ability to think in a positive and creative manner – challenge the status quo, question assumptions and parameters, and present new opportunities while inspiring the team and organization.

  • Strong impacting and influencing skills with the ability to effectively communicate to a diverse set of stakeholders and present complex and/or new ideas with clarity and simplicity.

  • Equal passion for implementing and driving successful execution.

  • Proven ability to build high performing collaborative teams, influence key stakeholders, lead and work effectively as part of a team.

  • Proven track record of leading organizations to a higher level of performance.

  • A proven history of driving significant change in a short-period of time in a positive and non-disruptive manner to the company’s values.

  • An exceptional leader as evidenced by his/her ability to lead a diverse organization, while building a collaborative and results-oriented group.

  • Knowledgeable and well-respected with the ability to attract and successful recruit other high impact people into the organization.

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#ptcareers

3/5/21 Business Systems Analyst II (TERM Position) Individual contributor South San Francisco, California

*TERM position for approximately 20 months

Purpose:

As a Computer Systems Business Analyst, you are responsible for providing general end user assistance, support and maintenance of new and existing Global Quality Computer Systems and Quality oversight as defined in Quality Policies Standards and Computer Software Validation. Problem solving, analytical and organizational skills are required. Lead or participate in business initiatives, IT projects, process improvements, system design teams, and Inspection prep/support activities by providing subject matter expertise. You will provide global subject matter expertise and support the implementation of the fit for purpose innovative solutions, including the information framework supporting the E2E process through the software development lifecycle (SDLC).   A successful candidate will have an agile and design thinking mindset.

Job Responsibilities:

  • Lead or participate on interdepartmental/global teams, process improvements, or new system design.

  • Make informed decisions on master data issues in collaboration with key stakeholders and abiding by system requirements.

  • Ensure the smooth introduction of new routine and complex master data functionality as they are added.

  • Act as a subject matter expert (SME)

  • Regularly evaluate business use of the software, master data and training materials to ensure alignment according to intended use.

  • Initiate and complete document changes as required to accommodate master data enhancements.

  • Provide maintenance and support for master data as required

  • Provide queries and ad-hoc reports as needed for Inspections/Audits and business purposes

  • Review and respond to problem reports, monitor issues and initiate resolutions

  • Initiate, investigate and close complex investigations and discrepancies.

  • Translate business needs into user requirements  for complex master data enhancements

  • Identify/Create user requirements based on knowledge of system use, GMP’s, Part 11 Requirements

  • Solve problems through effective troubleshooting and suggest viable solutions

  • Participate in the validation activities for the systems such as UATs.

  • Continuously improve systems achieving increased compliance and efficiency

  • Complete all assignments and projects in a timely manner.

  • Be flexible and adapt to changing work priorities as needed.

  • Experience with problem-solving and issue identification and resolution

  • Flexibility in problem solving, providing direction and work hours to meet business objectives

  • Ensure GMP Co­mputer Systems and their operation are in compliance and fit for intended use according to applicable procedures

  • Works with management to align projects to strategy and business objectives

  • Make informed decisions on software issues in collaboration with key stakeholders and abiding by system requirements

  • Regularly evaluate business use of the software and training materials to ensure alignment according to intended use

  • Initiate, investigate and close complex investigations and discrepancies

  • Use influence rather than authority when necessary to achieve results

Competencies:

Applying Technical Expertise

Applies company knowledge and solid technical expertise to complete complex assignments within defined parameters.   Demonstrates a solid understanding of Genentech/Roche and the functional organization being supported as well as impacts to other functional organizations. Ability to operate effectively in rapidly changing technology and business environments. Thoroughly skilled in assigned functionality.

Driving for Results

Ability to input, execute and deliver against a defined strategy or plan. Ability to quickly learn the business in unfamiliar areas.  Independently addresses complex problems with only manager/director buy-in.  Leads meetings and or represents organization on significant functional issues.  Ability to gather information from a number of sources, assess and prioritize and assimilate into a project proposal and or business case.

Decision Making

Exercise sound judgment when making decisions.  Make critical decisions in collaboration with key stakeholders.  Demonstrate accountability for personal, departmental and cross functional initiatives.  Ability to identify and mitigate risks. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

Communication

Skilled in writing and interpersonal communication.  Ability to identify and explain problems and solution alternatives to developers, project teams, and user groups.  Ability to quickly produce clearly written and well-organized documentation.   Ability to communicate cross-functionally using a variety of tools.  Strong ability to interact, communicate and influence within multiple levels of the organization. Provide routine updates on progress, status, and issues associated with system deployment and projects.  Influence or lead group decision-making, including evaluation of alternatives and recommendations. 

Collaboration and Teamwork

Proven skills in relationship building, customer focus, decision-making and problem-solving. Work effectively by encouraging collaboration, both within and across projects, functional areas and diverse employee groups.  Identify stakeholders and obtain buy-in on decisions and planning.  Voice opinions constructively, while actively supporting and implementing agreed upon goals and decisions in word, behavior and actions.  Team skills needed to participate in and lead cross-functional workgroups.  Take the lead in identifying and resolving conflicts both internal and external to the group. Interacts with senior internal and external personnel on significant matters.

Job Qualifications:

  • Bachelor’s Degree in an applicable field or equivalent

  • Minimum 5-7 years work experience in biopharmaceutical production and an understanding of the quality processes and procedures 

  • Working knowledge of one or more information packages (e.g., LIMS, LES, CDS, Plate Reading Software)

  • Strong interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

  • Flexibility in problem solving, providing direction and work hours to meet business objectives

3/5/21 Field Reimbursement Manager (FRM), Ophthalmology - NC/SC Ecosystem Individual contributor North Carolina

Ophthalmology Field Reimbursement Manager (FRM), NC/SC Ecosystem

Territory: Carolinas– Raleigh, Charlotte, Greenville, Columbia, Charleston, Morganton, Asheville, Winston-Salem (candidate will live in territory and cover all geographies in North and South Carolinas)

Position Overview

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

The Field Reimbursement Manager (FRM), Ophthalmology is integral to successfully delivering this vision by minimizing reimbursement barriers for patients and providers to optimize access to Genentech Ophthalmology products (LUCENTIS today, PDS and faricimab upon FDA approval). Within the context of an integrated ecosystem business plan, the FRM is responsible for partnering with internal colleagues to address access restrictions by strategically working with key decision makers to refine policies, empowering team members and customers to resolve access issues, and solving the most complex patient access cases. They also develop ethical and customer-oriented reimbursement strategies and proactively communicate payer criteria/terms and practices, as these relate to reimbursement for the assigned Genentech products in order to prevent potential access challenges.

Within the ecosystem, the FRM works closely with the Director, Healthcare Market, Ophthalmology (Ophtha HD), Therapeutic Area Manager (TAM), other FRMs in the respective ecosystems, and Access Solutions internal teams to ensure drug accessibility. The Ophtha FRM will represent LUCENTIS today, PDS and faricimab upon FDA approval.

Key Accountabilities

1. Work with internal partners to build strategic patient access and reimbursement account

plans and review squad and ecosystem business plans and objectives

2. As subject matter expert on the payer landscape relevant to assigned Genentech

therapeutic area/products, educate customers and partners on national, regional and local coverage policies and processes

3. Is a conduit between the Field and Home Office Genentech functions for all public and

private payer policies and practices that impact patient access to Genentech products

4. Urgently anticipate, navigate and address individual account and patient access (may

include patient identifiers) issues that occur by partnering with internal and external stakeholders including Access Solutions teams

5. Proactively communicate and explain Genentech-specific reimbursement programs, policies, procedures and resources so that HCP office staff is fluent in how to use access programs for Genentech products

6. Maintain compliant relationships with relevant state, local, institutional, or other societies

7. Keep abreast of customer and healthcare industry trends. Sees patterns or connections between situations; can envision and articulate possibilities and likelihoods. Initiates development actions to constantly adapt and grow capabilities to increase impact

8. Represent the Genentech Ophthalmology products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials

9. Lead, act and live our Operating Principles in all aspects of work

Qualifications

● Bachelor’s Degree required; MBA or other related graduate degree preferred

● 6 or more years cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry

● A minimum of 2 or more years direct experience with managed care and reimbursement is required, either directly within/from the pharmaceutical/biotech industry or relevant, large-scale practice management

● Must demonstrate excellent working knowledge of reimbursement and the practice management environment

● Demonstrated ability of applying reimbursement knowledge to address/resolve patient access barriers

● Previous experience with both private & public payers is strongly preferred. Buy and Bill, as well as specialty pharmacy experience preferred.

● Previous experience in other functions in the pharmaceutical/biotech industry is preferred, e.g. product marketing, managed care marketing, field sales/sales management, field account management, etc.

● Proven track record for consistently meeting or exceeding goals and objectives

● Previous experience in completing & implementing attainable business plans

● Understanding of external laws, codes and company policies that apply to the healthcare industry.

Operating Principles

I put the patient first, always.

I am obsessed with meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive. 

I build a culture of trust.

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify and prioritize for impact.

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Candidate must live within the ecosystem.  Although individual contributors in Ophtha may overlap a few ecosystems, this position will mostly work North and South Carolina and possibly southern portions of VA. Colorado applicants are not eligible

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.   Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society.  We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide  an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

The next step is yours. To apply today, click on the "Apply for this job" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

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3/4/21 Therapeutic Area Manager (TAM), Lung Pan Tumor - Michigan Ecosystem Individual contributor Michigan

Therapeutic Area Manager (TAM)

Position Overview

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

The Therapeutic Area Manager (TAM) is integral to successfully delivering this vision, working closely with healthcare providers. The TAM deeply understands the specific needs of healthcare practitioners in their therapeutic area to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care.

The TAM is empowered to own the business for their TA within the ecosystem and to optimize as appropriate; focused on improving the customer and patient experience across the care continuum. They will leverage other ecosystem and organization experts to provide customers with the information they need about products to make decisions that support enhanced patient outcomes, and to influence the ecosystem business strategy. The TAM will represent all relevant products and indications within the designated Therapeutic Area.

In alignment with the ecosystem and customer strategic plan, the TAM is accountable for driving on-label clinical demand to ensure HCPs identify the right medication for the right patient.

In addition, they are responsible for collecting ecosystem insights and trends and being a primary conduit between an ecosystem, the Squads and marketing to support the national strategy at a local level.  The TAM will represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials.

There are two levels of Therapeutic Area Managers. The difference is based on the scope, complexity and criticality to the ecosystem business as well as differences in expertise required to execute responsibilities.

Key Accountabilities

Serve as primary point of contact for their therapeutic area for their customers in the  ecosystem. Address and identify opportunities for pulling through ecosystem and TA squad strategies at the point-of-care Apply strong understanding of the specific needs of healthcare practitioners and mobilizes ecosystem and organization experts to partner with customers to identify and address their clinical and business goals and challenges in support of improved patient outcomes, lower costs and improved quality of care Contribute to the development and execution of customer account plans for target accounts to deliver maximum impact opportunities and business goals Deliver education to HCPs regarding product information, appropriate use, and dosing and administration based on FDA approved product information and formulary/pathways/guidelines (e.g. one on one interactions, in-services, identification of opportunities for peer-to-peer programming, etc.). Effectively triage to USMA experts as appropriate Address product acquisition (contract awareness, etc), and address supply matters through coordination of distribution issues, and managing spoilage and returns Ensure product access to provide proactive (and de-identified) education on patient assistance, reimbursement resources. Triage to HD and FRM as appropriate Keep abreast of customer and healthcare industry trends. Initiates development actions to constantly adapt and grow capabilities to increase impact Represent the Genentech products to the highest ethical and professional standards and in accordance with guidelines and PRC approved materials Lead, act and live our Operating Principles in all aspects of work

Qualifications

  • Scientific or clinical degree, Bachelor’s degree level at minimum
  • Previous cross-functional industry experience in commercial life sciences (pharma or biotechnology) or related industry engaging with key healthcare ecosystem players (e.g., payers, health systems), is required
  • 4 or more years experience working in a sales role with HCPs, ideally representing multiple products and working across a complex healthcare system environment
  • Clinical nurse or Advanced Practice Nurse (APN) experience highly valued
  • Ability to work in an ambiguous environment undergoing transformation is a strong plus
  • Proven track record in coaching, training and/or mentoring peers or others as assigned; helping such others to better meet or exceed their goals, targets and other responsibilities
  • Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals
  • Self starter; ability to seek out relevant information, prioritize, and apply information to solve complex problems in the ecosystem
  • Ability to assimilate and communicate complex clinical and product information
  • Knowledge of and ability to successfully addressing operational issues in the delivery of healthcare products to patients, such as reimbursement and supply
  • Understanding of external laws, codes and company policies that apply to the healthcare industry

CMG Operating Principles

I put the patient first, always.

I am tenacious in meeting customer needs.

I act on behalf of the whole company, not just my team.

I am inclusive. 

I build a culture of trust.

I grow my capabilities to increase my impact.

I have a bias for action.

I am accountable.

I use time and resources to create the most impact.

I act with integrity.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

It is highly preferred the candidate live within the ecosystem.

Colorado applicants are not eligible. 

This is a field-based position and overnight travel may be required. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

3/4/21 Medical Affairs Executive Director, Mega National Accounts (Remote) Manager without direct reports California

Medical Affairs Executive Director, Mega National Accounts

Position Overview

From the beginning, Genentech has been a team of highly dedicated, passionate individuals. We are a place where people are united around a single purpose and an ambitious vision. Together, we aspire to deliver ever better health outcomes for patients while lowering overall healthcare costs.

The Medical Affairs Executive Director, Mega National Accounts is a cross-portfolio role, accountable for co-creating and driving an overarching medical strategy across organizations with national scope, including Payers, Federal, National Comprehensive Cancer Network / pathway vendors, Channel, Hospital and Distribution customers with the goal of shaping strategies for optimized access and formulary positioning of Genentech products while at the same time seeking to improve patient outcomes and customer experience. In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.

The Medical Affairs Executive Director, Mega National Accounts will have field accountability for key customers and will be responsible for collaborating closely with MED roles focused on local healthcare regions to gain alignment and execute against shared medical goals and ensure national decisions are pulled through at the local level. The Medical Affairs Executive Director, Mega National Accounts will work in close partnership with their commercial National Accounts counterparts to ensure shared accountability across the designated accounts, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience. The Medical Affairs Executive Director, Mega National Accounts is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their team.

The Medical Affairs Executive Director, Mega National Accounts will provide medical leadership for defined teams to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value.

Key Accountabilities:

1. Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs

2. Connect with key medical customers to co-create solutions leveraging Genentech/Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum

3. Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products

4. Define the strategic near and long-term medical vision and direction for the defined National Accounts in order to identify opportunities for collaboration which enhance patient outcomes and experience

5. Lead and influence national field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across the nation

6. Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities:

● Primary medical point of contact for defined National Accounts to co-create, prioritize,

plan, and implement mutual beneficial, cross portfolio or population health initiatives that

are aligned with account and U.S. Medical Affairs (USMA) priorities

● Lead development and execution of medical strategy and vision (with local healthcare

region medical partners) aligned with the broader organization and provide ongoing

visibility of account plans to all relevant stakeholders

● Foster amongst team ongoing awareness of cross-functional disease area leadership

team and USMA objectives and strategy to integrate into account plans across the

nation

● As needed, facilitate and coordinate Therapeutic Area MSL (TA MSL) touchpoints to

optimize medical engagements with defined National Accounts customers. Partner with

TA MSLs for discussions that require deep scientific, technical expertise

● Help determine allocation of resources and make investment decisions to maximize

patient outcomes and customer engagement while delivering value for Genentech

● Ability to provide high level scientific engagement across the Genentech portfolio of

products, to include pipeline presentations across all key disease and therapeutic areas

● In partnership with the commercial National Accounts team, establish and manage

senior stakeholders and C-suite relationships across the defined National Accounts in

order to better understand their needs and identify insights and opportunities for medical

collaboration

● Identify and co-create research collaboration opportunities across National Accounts

customers to address key questions in the delivery of patient care

● In conjunction with the National Accounts field team:

● Identify and establish health outcomes and RWE collaborations that leverage

capabilities of the nation

● Identify scientific research priorities with local healthcare region medical partners,

other national health services researchers, or through appropriate internal

stakeholders (medical teams, health outcomes research teams, development,

etc.)

● Collaborate with commercial National Accounts team to ensure appropriate triage

of commercial opportunities while leveraging medical staff for appropriate

discussions and support  

● Support national healthcare market opportunities (e.g., Oncology Care Model)

● Represent cross portfolio customer needs, insights and knowledge to other parts of

Genentech including senior leadership and other internal partners (i.e. cross-functional

disease area leadership team, medical teams, health outcomes research teams, etc.) in

order to advance shared goals between Genentech and the customer

● Identify, facilitate, and pull through training needs for defined National Accounts team

and beyond to ensure team members are competent in evolving market landscape

● Track National Accounts customer experience, both formally and informally, and use this

information to enhance customer engagement and medical strategy

● Develop and track metrics across the medical portfolio in partnership with commercial

National Accounts team, when appropriate to include – total number of clinical trials by

disease area, performance across clinical trials, delivery on research initiatives, clinical

pathway and guideline implementation and utilization, formulary status, etc. Identify

opportunities through analytics and ongoing business reviews and using agile

approaches to adapt medical plans where required

● Create and foster a culture that is collaborative and customer centric, and a team that is

curious about possibility and empowered for action

● Lead change and encourage a mindset of experimentation and innovation to continually

refresh and enhance the customer experience

● Attend and represent Genentech through advisory panels, advisory boards and other

professional and/or policy-making forums to influence the healthcare debate and

advance Genentech’s mission to be the leading biotechnology company in the U.S.

● Comply with all laws, regulations and policies that govern the conduct of Genentech

activities

●This position may be accountable for covering more than one National Account pending

business needs

Qualifications

● Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA,

etc.)

● 10 years related work experience strongly preferred (managed care/health plan, hospital

administration, clinical pathway or formulary decision maker, industry experience, etc)

with demonstrable evidence of successfully partnering with customers and achieving

shared goals and outcomes

● Developing and implementing strategy across complex healthcare environments with an

ability to influence without authority and mobilize colleagues to action around shared

goals

● Ability to lead complex cross-functional account teams and operating under ambiguity

without a set playbook, including aligning teams

● Strong ability to lead, influence, and work in a matrixed environment regardless of

reporting structure

● Ongoing investment in developing self and others to enable others to achieve their

potential, deliver ambitious goals or achieve excellence

● Excellent understanding of external laws, codes and company policies that apply to the

healthcare industry

Genentech Operating Principles

● I put the patient first, always.

● I am obsessed with meeting customer needs.

● I act on behalf of the whole company, not just my team.

● I am inclusive.

● I build a culture of trust.

● I have a growth mindset.

● I act with urgency.

● I am accountable.

● I radically simplify & prioritize for impact.

● I follow the science.

● I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

This position requires significant driving of either a company provided or personal vehicle as

well as prolonged periods of sitting, both of which are part of the essential duties and

responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

This is a field-based position. Must be willing to travel overnight to meet with customers, internal stakeholders, and attend relevant conferences up to 70% time.

Colorado applicants are not eligible.

#LI-Remote

#LI-CG2

3/4/21 Scientist, OMNI Biomarker Development Individual contributor South San Francisco, California

Who We Are

The OMNI-Biomarker Development department at Genentech provides translational science support to inform the clinical development of novel personalized therapeutics in disease areas of Ophthalmology, Metabolism, Neuroscience, Immunology and Infectious Diseases (OMNI). Our biomarker strategies are designed to study the molecular pathways driving the disease and to establish the mechanism of action of our therapeutics. We focus on prognostic, predictive and pharmacodynamic biomarkers to enable our vision of “the right drug for the right patient at the right dose.”

The Position

We are seeking a highly motivated Scientist to join the OMNI-Biomarker Development Department within Development Sciences to drive our biomarker and drug development efforts in multiple sclerosis. Our department is responsible for defining biomarker and personalized healthcare strategies, designing and implementing biomarker assays in clinical trials, and interpreting biomarker results. Our group uses relevant biomarkers to evaluate disease heterogeneity, target-engagement, mechanism of action, and disease modification; and to guide clinical diagnostic biomarker development. Biomarker team leaders within the department provide scientific leadership for biomarkers in clinical trials ranging from early proof-of-concept through marketed products.

Responsibilities

The successful candidate will join our dynamic team and work to identify biomarkers in support of drug development projects in multiple sclerosis.  The candidate will support multiple trials, lead efforts for data generation and analyses within internal studies and as part of external academic collaborations relating to understanding biomarkers in multiple sclerosis. The successful Scientist will have the opportunity to grow into a project biomarker team leader. Success in these responsibilities requires a thorough understanding of disease and drug target biology, creativity and attention to detail, and experience in integrating biomarkers into clinical trials. Candidates familiar with molecular/immunological techniques and analytic methods including immunoassay, qPCR, genetics, gene expression analysis, cellular immunology, or analytics (knowledge of R or other data analysis programming experience) will be given preference. The position requires working in close partnership across various functions including Research, Bioanalytical Assay Department, Diagnostics, Clinical Sciences, Biostatistics, Bioinformatics, Regulatory and with external partners. Effective communication is essential and includes presentations at cross-functional teams, internal review committees, and external conferences, and will also involve writing biomarker sections of clinical protocols, reports, regulatory filings and scientific publications.

Who You Are

Candidates must have a PhD or MD in Neurology, Neuroscience and/or Immunology, or a related field with at least 2 years of post-doctoral or fellowship experience in basic or translational research either in an academic and/or industry setting.  The candidate must demonstrate a high level of independence and be able to develop hypotheses and direct analysis plans. Strong writing and communication skills are required, as evidenced by publications, meeting abstracts and/or drug development reports. We are looking for an individual who would be passionate about using their understanding of disease biology to make impactful contributions to clinical drug development. Willingness to collaborate across time zones including our Swiss site is a must.  Preferred candidates will have prior experience in multiple sclerosis and a demonstrated ability to function as part of a cross-functional team such as research or clinical trial project teams.

#LI-GENEKC1

3/4/21 BioAnalytical Manager Individual contributor South San Francisco, California

BioAnalytical Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies. Through global collaboration and robust portfolio management, our team brings technical and operational expertise along with passion and drive to make a difference for patients.

Job Scope:

The BioAnalytical Manager (BAM) provides bioanalytical operational expertise to local (PET) and global (SMT) clinical study teams to implement and execute strategies for anti-drug antibody (ADA) and pharmacokinetic (PK) analysis for all phases of clinical studies for Genentech programs. The BAM serves as a single point of contact between scientific functions (BAS, Clinical Pharmacology, DMPK), CROs, and clinical study teams for each clinical study to operationalize sample collection logistics, execute bioanalysis, and facilitate timely delivery of data to internal stakeholders and clinical study teams.

Primary Responsibilities:

May work with pharmacology sub-teams to provide input on PK/ADA deliverable timing, PVC input during PAR team review, and to understand clinical program development direction (filings, new studies) to ensure program needs are met.

Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs. Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual. Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle. Authors and reviews relevant sections of study related documents (i.e., central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.).

Develops study-specific sample and data flows plans with stakeholders (e.g. BAMP). Develops and manages timelines for bioanalytical labs to ensure samples are tested according to protocol and data is transferred in the specified format per study team timelines.

Assists function with outside spend (PVC) budget planning and management of actual spend (invoices, PO) for studies.

Contributes to identification of bioanalysis CROs and set up of contracts for bioanalysis, working with internal contacts. Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide inputs on CRO performance, escalating concerns as appropriate.

May assist with training and participate on organizational initiatives to support business needs. Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).

Education and Experience Requirements:

Bachelor’s degree or higher in biology, chemistry, or related scientific discipline. Project management certification desirable.

8-11 years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.

Working knowledge of ICH GCP.

Skills:

Highly effective verbal and written communication.

Ability to make sound decisions with limited information in a changing landscape, influence, and negotiate effectively, using appropriate judgement.

Highly motivated and proactive in performing work independently with a problem-solving mindset.

Demonstrated evidence of successful collaboration and delivery of results in a highly matrixed organization, working with culturally and geographically diverse teams.

Excellent organization and project management skills with high attention to detail to independently manage multiple projects with competing priorities.

#DevSci

#LI-HB2

3/4/21 Case Monitoring and Resolution Engineer Individual contributor Barcelona

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. 

Our success is built on innovation, curiosity and diversity. Roche is one of the highest spender on research and development (R&D) among global pharmaceuticals, spending more than 20% of revenue. This substantial investment has resulted in products that have advanced the understanding of disease and transformed the practice of medicine. 

At the same time, sustainability is an integral part of Roche’s business. We are committed to mitigate environmental impact and climate change, proactively seeking new, more sustainable technologies to achieve this goal. For the eleventh time, Roche has been recognised as the most sustainable company in the Pharmaceuticals index of the Dow Jones Sustainability Indices (DJSI).

We recognize the importance of work-life balance and personal well-being, considering flexible working options, including remote working, and respecting personal downtime for all roles. We strive to provide our employees with the best possible work environment. For many years, Roche has been consistently ranked as a great place to work by its employees and by external institutions. Furthermore, we are proud to be an equal opportunity employer, offering extensive training and development opportunities that enable all people to bring their unique selves to Roche. 

At Case Investigation and Resolution (CIR) department, you will learn about laboratory automation and software solutions, as well as varied regulatory requirements and quality practices in the area of medical technology. In this challenging department, you will have freedom for innovation and creativity. In addition, you will have autonomy and flexibility in how to approach your day-to-day tasks, mentored and guided by more senior members of the team. At CIR, we strive for an agile mindset in our daily work, focusing on achieving the best for patients and continuously working on improving our solutions. 

Details of the position

Main tasks:

- Assumes responsability under the supervision of a Senior member of the team for the management of individual cases (Inquiries, Complaints) in the area assigned according to regulatory and ISO Quality system requirements and needs of the Country Organizations in a timely manner.

- Resolves cases in the assigned area, potentially requiring consultation with more senior team members on technical or process-related aspects.

- Pro-actively consults / involves a more senior team member in cases not following pre-determined / prescribed process.

- Performs correct processing and documentation for individual cases in the area assigned.

- Cases need to be auditable and well documented to be self-explanatory to a person who has no specialized product or process knowledge (e.g. in an audit).

- Could represent and communicate result of individual case/issue in interfacing meetings.

- Assumes responsibility for providing information from cases in order to update product documentation.

Additional tasks:

- Contributes to initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.

- Ensures knowledge transfer to new employees.

- Could contribute in task forces for individual case/issue in their area of competency.

- Permanently optimizes processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.

- Browse the code repository and consult source code files when required to ensure a correct investigation but never making any modifications in the repository or the checked-in source code.

Requirements:

Education:

- Graduate Degree from a University of Applied Sciences or from a Professional Education and Training (PET) College (Higher Technical Schools) or equivalent professional experience.

- Vocational training in technical area completed with Federal Vocational Baccalaureate and several years of work experience

Competencies (skills and behaviors required):

- Sound technical product knowledge and principle of operation:

- intended use

- customer workflow

- principle of assay, system functionality

- Good appreciation of how product is used by the customer and their environment

- Basic understanding of business context for the products assigned

- Process Knowledge: full understanding

- Versed in the technology, at the level required to be able to converse with a 1st level representative of an Affiliate who already investigated and raised the issue to global

- Ability to apply troubleshooting / problem solving methodology

- Ability to draw conclusions on individual cases, potentially requiring consultation with Senior Scientist / Engineer or Principal

- Ability to effectively communicate with interfaces (e.g. Affiliates, Safety Board, R&D Experts)

- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).

- Main focus lies on the cobas infinity IT solution

Languages:

-Strong communication skills in English (written and spoken) are essential

- Knowledge of other languages is a plus

Specific Requirements (Job related experience):

- Work experience in the area of medical technology in either 1st or 2nd level support or R&D related functions

- Knowledge of the diagnostic market is desired

- Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)

Travel Requirements:

Approximately 5-10% of time

Working for Roche means more than just having a job. Guided by integrity, courage and passion, working for Roche means innovating diagnostics, shaping healthcare and changing lives. Apply now and be part of our team!

3/4/21 Medical Affairs Executive Director - CA, HI (Ecosystem) Remote Manager without direct reports California

Position Overview

The Medical Affairs Executive Director (MED) - CA, HI (Ecosystem) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 



Key Accountabilities

  • Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
  • Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
  • Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
  • Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
  • Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
  • Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

  • Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
  • Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
  • Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
  • As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
  • Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
  • Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
  • In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
  • Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
  • In conjunction with the region’s field team:
    • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
    • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
    • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
    • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
  • Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
  • Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
  • Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
  • Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
  • Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
  • This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
  • Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
  • This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

  • Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
  • 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
  • Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
  • Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
  • Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
  • Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
  • Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

Genentech’s Operating Principles

I put the patient first, always. 

I am obsessed with meeting customer needs.

I act on behalf of the whole company, not just my team. 

I am inclusive.  

I build a culture of trust. 

I have a growth mindset.

I act with urgency.

I am accountable.

I radically simplify & prioritize for impact.

I follow the science.

I build our reputation.

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Colorado applicants are not eligible.

#LI-CG2

#LI-Remote

3/4/21 Medical Affairs Executive Director - New York Metro (Ecosystem) Remote Manager without direct reports New York

Position Overview

The Medical Affairs Executive Director (MED) is a cross portfolio role,  responsible for co-creating and driving an overarching medical strategy across a local healthcare region with the goal of improving patient outcomes and customer experience.  In collaboration with other field partners, the MED will develop a deep understanding of the local healthcare region across health systems, payers, and other key influencers in the region.  In addition, they will identify opportunities to advance the care continuum and the delivery of healthcare through broad clinical and population health research opportunities that include Real World Evidence (RWE) and the ability to leverage the suite of Roche assets across Flatiron Health, Foundation Medicine, and Roche Diagnostics as appropriate.  The MED will have field accountability with key customers in the ecosystem and will be responsible for collaborating closely with therapeutic area MSLs (TA MSLs) within the same region to gain alignment and execute against shared medical goals. The MED will work in close partnership with their commercial counterpart, the Healthcare Market Executive Director (HED), to ensure shared accountability across the designated region, being fully accountable for delivering on the medical aspects of the business and the overarching customer experience.  The MED is also responsible for leading change management, supporting people development, and identifying enhanced competency opportunities for their region’s team. 

The MED will provide medical leadership for a defined region’s team to deliver an enhanced end to end customer experience and greater engagement in the delivery of health care solutions, inclusive of patient outcomes, customer satisfaction, and joint value. 



Key Accountabilities

  • Deeply understand the unique medical needs of each customer in their clinical, research, and business goals to increase satisfaction, improve outcomes and lower overall healthcare costs
  • Connect with key medical customers to co-create solutions leveraging Genentech/ Roche capabilities (inclusive of our medicines, services, technology, talents) along the healthcare continuum.
  • Prioritize relationships with key access decision-makers in healthcare systems, managed care organizations, payers, and government programs to optimize appropriate coverage policy, pathway inclusion, patient identification algorithms; further developing medically driven mitigation strategies to remove barriers impacting patients access to Genentech products  
  • Define the strategic near and long-term medical vision and direction for the healthcare region in order to identify opportunities for collaboration which enhance patient outcomes and experience
  • Lead and influence regional field medical discussions across therapeutic areas to identify and elevate medically focused opportunities, resources, and strategic action across regions
  • Act with executive ownership mindset with a focus on a comprehensive medical strategy in order to achieve optimal outcomes for patients

Key Activities & Responsibilities 

  • Primary medical point of contact for large customers in their region to co-create, prioritize, plan, and implement mutual beneficial, cross portfolio or population health initiatives that are aligned with account and U.S. Medical Affairs (USMA) priorities
  • Lead development and execution of medical strategy and vision (with TA MSLs) aligned with the broader organization and provide ongoing visibility of account plans to all relevant stakeholders
  • Foster amongst team ongoing awareness of the cross-functional disease area leadership team and USMA objectives and strategy to integrate into account plans across the region
  • As needed, facilitate and coordinate TA MSL touchpoints to optimize medical engagements with shared region customers.  Partner with TA MSLs for discussions that require deep scientific, technical expertise
  • Help determine allocation of resources and make investment decisions to maximize patient outcomes and customer engagement while delivering value for Genentech
  • Ability to provide high level scientific engagement across the Genentech portfolio of products, to include pipeline presentations across all key disease and therapeutic areas
  • In partnership with the HED, establish and manage senior stakeholders and C-suite relationships across the region in order to better understand their needs and identify insights and opportunities for medical collaboration
  • Identify and co-create research collaboration opportunities across customers within a region to address key questions in the delivery of patient care
  • In conjunction with the region’s field team:
    • Identify and establish health outcomes and RWE collaborations that leverage capabilities of the region
    • Identify scientific research priorities with TA MSLs, other region health services researchers, or through appropriate internal stakeholders (medical teams, health outcomes research teams, development, etc.)
    • Collaborates with HED to ensure appropriate triage of commercial opportunities while leveraging medical staff for appropriate discussions and support  
    • Supports geographic or local healthcare market opportunities (e.g., Oncology Care Model)
  • Represent cross portfolio customer needs, insights and knowledge to other parts of Genentech including senior leadership and other internal partners (i.e. cross-functional disease area leadership team, medical teams, health outcomes research team, etc.) in order to advance shared goals between Genentech and the customer.  
  • Identify, facilitate, and pull through training needs for the region field medical partners and beyond to ensure team members are competent in evolving market landscape
  • Track the region’s customer experience, both formally and informally, and use this information to enhance customer engagement and medical strategy 
  • Develop and track metrics across the medical portfolio in partnership with HED, when appropriate to include – total number of clinical trials by disease area, performance across clinical trials, delivery on research initiatives, clinical pathway and guideline implementation and utilization, formulary status, etc.  Identify opportunities through analytics and ongoing business reviews and using agile approaches to adapt medical plans where required  
  • Create and foster a culture that is collaborative and customer centric, and a team that is curious about possibility and empowered for action  
  • This position will have direct accountability for providing coaching and feedback to their region partners.  In some regions depending on size, complexity, and geography, this position could be a role with management responsibilities for field medical personnel in the region
  • Lead change and encourage a mindset of experimentation and innovation to continually refresh and enhance the customer experience 
  • This position may be accountable for covering more than one healthcare region pending business needs

Qualifications

  • Advanced clinical science degree required (MD, PharmD, MsRPH, PhD, MSN, NP, PA, etc.)
  • 10 years related work experience strongly preferred (managed care/health plan, hospital administration, clinical pathway or formulary decision maker, industry experience, etc.) with demonstrable evidence of successfully partnering with customers and achieving shared goals and outcomes
  • Developing and implementing strategy across complex healthcare environments with an ability to influence without authority and mobilize colleagues to action around shared goals
  • Ability to lead complex cross-functional account teams and operating under ambiguity without a set playbook, including aligning teams
  • Strong ability to lead, influence, and work in a matrixed environment regardless of reporting structure
  • Ongoing investment in developing self and others to enable others to achieve their potential, deliver ambitious goals or achieve excellence
  • Excellent understanding of external laws, codes and company policies that apply to the healthcare industry

CMG Operating Principles

● I put the patient first, always.

● I am obsessed with meeting customer needs.

● I act on behalf of the whole company, not just my team.

● I am inclusive.

● I build a culture of trust.

● I have a growth mindset.

● I act with urgency.

● I am accountable.

● I radically simplify and prioritize for impact.

● I follow the science.

● I build our reputation. 

Complies with all laws, regulations, policies and procedures that govern the conduct of Genentech activities.

 It is highly preferred the candidate live within the region.  

This is a field-based position and requires overnight travel to meet with customers, internal stakeholders, and attend relevant conferences as needed. This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.

Colorado applicants are not eligible.

#LI-CG2

#LI-Remote

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Important Information

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity protections, view the EEO is the poster.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at [email protected].

Genentech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.