The Clinical Operations Leader will provide strategic direction and leadership to the assigned therapeutic area(s) (TA) and other bodies on the Clinical Operations aspect of the Genentech USMA portfolio. Additional accountabilities include the implementation and execution of all Clinical Operations activities, concerning all programs within the assigned TA(s) for USMA.

In this role, the COL will be a standing member of the USMA Clinical Operations Leadership Team and the EG Leaders will contribute to defining and implementing USMA EG’s vision, priorities, and strategy. The incumbent will also manage a team of direct reports, which may include Clinical Program Leaders, Senior Clinical Trial Leaders and contingent workforce employees to deliver on projects in line with USMA operational plans and overarching USMA strategy. COLs will also partner with a broad set of senior stakeholders across the portfolio to enable smart development and delivery of the USMA portfolio. The COL may represent USMA or EG on enterprise-wide WPTs or initiatives.

The COL position leads the development of Disease Area Operational Strategy by designing strategic frameworks to inform operational delivery of the portfolio; enhancing cross functional collaborations and practices to support efficient execution on the operational strategy; developing a long term disease area operational strategy to support future operations of USMA clinical trials; and accountable to forecast and manage staff resource needs to ensure timely and efficient, appropriately qualified resourced are assigned to project/studies.

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

Key Responsibilities/Accountabilities:

In this position, you will be primarily accountable for consistently, effectively:

● Providing leadership, coaching, and line management to USMA EG staff in the assigned disease area(s).

● Providing strategic guidance to the CPLs personnel on their programs to ensure they are contributing at a high level of excellence on their teams to support USMA medical strategy execution and overall success across the assigned TA(s)

● Ensuring the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution.

● Overseeing and guiding USMA clinical programs and associated clinical studies operations across the assigned TA(s), and assuming accountability for such, to ensure delivery of clinical operations activities to meet study plans outlined by medical plans.

● Providing direction and leadership to USMA Clinical Operations teams dedicated to assigned TA(s); includes ensuring appropriate CRO and other vendor oversight

● Collaborating effectively with leaders and staff within and outside USMA EG Clinical Operations to ensure USMA EG is meeting its business objectives

● Ensuring USMA Clinical Operations teams for the assigned therapeutic area(s) compliantly develop and cultivate productive relationships with external partners/stakeholders

● Anticipates new trends in competitive or disease area landscape to guide organizational strategy accordingly.

● Assessing different operating models to incorporate new and novel approaches to planning and execution of clinical programs within assigned therapeutic area(s).

● Ensuring that risk and quality plans are robust, proactive and implemented for all studies and related activities across the assigned therapeutic area(s)

● Applies strong analytical skills to translate data to strategies and action plans.

● Driving study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement of both systems and processes

● Ensuring the assigned USMA Clinical Operations team(s) meets or exceeds assigned goals and objectives

● Aligning, motivating and inspiring your team to work in accordance with broader Roche, Genentech and Medical Affairs strategies and goals

As a member of the USMA Clinical Operations leadership team:

·       Contributes to defining and implementing the strategic direction, objectives and goals for the portfolio, as well as the therapeutic area(s).

·       Provides a consolidated overview of programs within their therapeutic area(s) including the strategy, status and project issues.

·       Works with other leaders to remove barriers at the program level, within their therapeutic area(s).

·       Contributes actively to making the USMA EG Therapeutic Area Team into a highly functioning team

Requirements:

● Previous Experience Required or Preferred in Related Field

o 10 or more years’ experience in a leadership role in pharmaceutical/biotechnology research and development o 4 or more years’ people management experience o 2 or more years’ experience in medical affairs is preferred o Experience in managing large budgets o Global trial experience is preferred

● Knowledge, Skills and Abilities

o Comprehensive knowledge of ICH-GCP and other relevant standards and guidelines o Comprehensive knowledge of operational aspects of clinical trial management and the drug development process o Knowledge of relevant therapeutic area(s) is preferred

●Technical Experience

o Expertise in the assigned therapeutic area(s) or ability to quickly learn scientific area

● Educational Background

o Bachelor's Degree in a medical/science-related discipline o Graduate or high-level degree in relevant disciplines is preferred

The Clinical Operations Leader will provide strategic direction and leadership to the assigned therapeutic area(s) (TA) and other bodies on the Clinical Operations aspect of the Genentech USMA portfolio. Additional accountabilities include the implementation and execution of all Clinical Operations activities, concerning all programs within the assigned TA(s) for USMA. Leads and manages a Clinical Operations function and team for the USMA OMNI (Neuroscience, Immunology, Respiratory and Ophthalmology) division. 

In this role, the COL will be a standing member of the USMA Clinical Operations Leadership Team and the EG Leaders will contribute to defining and implementing USMA EG’s vision, priorities, and strategy. The incumbent will also manage a team of direct reports, which may include Clinical Program Leaders, Senior Clinical Trial Leaders and contingent workforce employees to deliver on projects in line with USMA operational plans and overarching USMA strategy. COLs will also partner with a broad set of senior stakeholders across the portfolio to enable smart development and delivery of the USMA portfolio. The COL may represent USMA or EG on enterprise-wide WPTs or initiatives.

The COL position leads the development of Disease Area Operational Strategy by designing strategic frameworks to inform operational delivery of the portfolio; enhancing cross functional collaborations and practices to support efficient execution on the operational strategy; developing a long term disease area operational strategy to support future operations of USMA clinical trials; and accountable to forecast and manage staff resource needs to ensure timely and efficient, appropriately qualified resourced are assigned to project/studies.

All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.

Key Responsibilities/Accountabilities:

In this position, you will be primarily accountable for consistently, effectively:

● Providing leadership, coaching, and line management to USMA EG staff in the assigned disease area(s).

● Providing strategic guidance to the CPLs personnel on their programs to ensure they are contributing at a high level of excellence on their teams to support USMA medical strategy execution and overall success across the assigned TA(s)

● Ensuring the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution.

● Overseeing and guiding USMA clinical programs and associated clinical studies operations across the assigned TA(s), and assuming accountability for such, to ensure delivery of clinical operations activities to meet study plans outlined by medical plans.

● Providing direction and leadership to USMA Clinical Operations teams dedicated to assigned TA(s); includes ensuring appropriate CRO and other vendor oversight

● Collaborating effectively with leaders and staff within and outside USMA EG Clinical Operations to ensure USMA EG is meeting its business objectives

● Ensuring USMA Clinical Operations teams for the assigned therapeutic area(s) compliantly develop and cultivate productive relationships with external partners/stakeholders

● Anticipates new trends in competitive or disease area landscape to guide organizational strategy accordingly.

● Assessing different operating models to incorporate new and novel approaches to planning and execution of clinical programs within assigned therapeutic area(s).

● Ensuring that risk and quality plans are robust, proactive and implemented for all studies and related activities across the assigned therapeutic area(s)

● Applies strong analytical skills to translate data to strategies and action plans.

● Driving study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting continuous improvement of both systems and processes

● Ensuring the assigned USMA Clinical Operations team(s) meets or exceeds assigned goals and objectives

● Aligning, motivating and inspiring your team to work in accordance with broader Roche, Genentech and Medical Affairs strategies and goals

As a member of the USMA Clinical Operations leadership team:

·       Contributes to defining and implementing the strategic direction, objectives and goals for the portfolio, as well as the therapeutic area(s).

·       Provides a consolidated overview of programs within their therapeutic area(s) including the strategy, status and project issues.

·       Works with other leaders to remove barriers at the program level, within their therapeutic area(s).

·       Contributes actively to making the USMA EG Therapeutic Area Team into a highly functioning team

Requirements:

● Previous Experience Required or Preferred in Related Field

o 10 or more years’ experience in a leadership role in pharmaceutical/biotechnology research and development o 4 or more years’ people management experience o 2 or more years’ experience in medical affairs is preferred o Experience in managing large budgets o Global trial experience is preferred

● Knowledge, Skills and Abilities

o Comprehensive knowledge of ICH-GCP and other relevant standards and guidelines o Comprehensive knowledge of operational aspects of clinical trial management and the drug development process o Knowledge of relevant therapeutic area(s) is preferred

●Technical Experience

o Expertise in the assigned therapeutic area(s) or ability to quickly learn scientific area

● Educational Background

o Bachelor's Degree in a medical/science-related discipline o Graduate or high-level degree in relevant disciplines is preferred

We are seeking a highly motivated Scientific Researcher/Senior Scientific Researcher to join the Cytometry Biomarker group within Development Sciences. Our group is responsible for designing and implementing biomarker assays for programs in clinical development at Genentech in immunology, immuno-oncology, hematological oncology, and other new therapeutic areas.



The successful candidate will join our dynamic team and work to design and implement flow cytometry biomarkers in early and late stage clinical trials of novel therapeutics in our growing pipeline. The desired candidate will have a solid understanding of immunology and cancer biology; demonstrate strong expertise in immunological cell subsets such as effector and regulatory T, B, and/or monocyte subsets; and understand the biomarkers used in flow cytometry to identify these populations in vivo. 

• Attention to detail, good communication, and collaboration skills will be essential to excel in this position
• Proven cell biology expertise working with a variety of sample types including whole blood, bone marrow, cell lines and single-cell suspension from tissue samples is expected
• Ability to design and execute the development and validation of 8+ color cytometry assays is essential
• Experience with and enthusiasm for higher complexity (+18 color) cytometry platforms is preferred
• Experience with advanced bioinformatics tools (e.g. ‘R’ scripts, spotfire) for analyzing and visualizing biomarker data is highly valued
• Strong analytical skills and judgment in assessing the quality of assay data and assay performance will be needed to be successful in this role
• Must be self-motivated, able to multi-task, and meet timelines efficiently and productively

Scope of position:

This position will report to the Senior Scientific Manager of the Cytometry Biomarker group within the Development Sciences Division of Genentech Research and Early Development. The individual will lead development and execution of cytometry biomarker activities supporting one or more molecules and indications in the non-oncology and oncology disease areas to better understand mechanisms of drug action, response and resistance. Scope of biomarker activities will span predictive, pharmacodynamic, and prognostic biomarkers as well as response markers such as MRD (minimal residual disease).

Requirements

B.A./B.S. or M.S degree in life sciences, with at least 3 years of relevant experience, preferably in the industry setting, is required.  A strong knowledge of flow cytometry is essential, with proficiency in traditional manual gating approaches such as FCS Express or FloJo®.  Candidates with enthusiasm and experience to adopt advanced analytical tools such as unsupervised and supervised automated analysis (e.g. tSNE, FLOWDensity, FLOWSom) will be given preference.   Hands-on lab experience with human cell based assays is preferred.  The candidate must demonstrate a high level of independence and be able to develop hypotheses and analysis plans for immunology and oncology associated cytometry biomarker data. The candidate will have a demonstrated ability to function as part of a cross-functional team. Strong writing and communication skills are required, as evidenced by publications and/or drug development reports.  Experience with outsourcing flow cytometry assays to contract research organizations (CRO) is highly desirable.

#LI-GENEKC1

The Scientific Researcher will be responsible for daily instrument set-up and preparation, maintenance, trouble-shooting, and operation of the Flow sorters, analyzers, and other instrumentation in the lab. Sorting instruments include: 6 BD FacsAria Fusions, 2 BD FacsArias, and a BD Influx. Analyzers include 2 BD Dual Symphonys, 1 BD Dual Fortessa, 1 BD single Fortessa, 4 BD Symphony A5s, 2 BD Celestas, and 2 BD FacsCaliburs.  Other instruments include an Amnis ImageStream system, a Helios Mass Cytometer, and a Hyperion tissue Imager.

Responsibilities:

• The individual will be responsible for cell sorting and assisting with cell analysis, including data analysis and presentation, for the many researchers at Genentech who use the core Facs Facility. Users are typically from the Immunology, Molecular Biology, Medicinal Chemistry, and Early Stage Cell Culture departments.
• She/he will also be responsible on a rotating basis for doing cytokine/chemokine analysis using the Luminex system in the Luminex annex of our lab, for many researchers at Genentech who request this data.  We have available robots for setting up requested assays, as well as Luminex 200’s and FlexMaps for analyzing the generated multiplex data.

Requirements:

• The applicant should have a bachelor's or master's degree in one of the Biological sciences, and possess the instrumentation skills to operate, manage, trouble-shoot, and maintain the sorters, analyzers, and other systems.  Good computer skills are essential.
• In addition, and equally important, are good communication skills, a teamwork spirit, the ability to work with a large, diverse group of researchers, and the flexibility to provide support for experiments that do not always fit into a regular schedule.  Preference will be given to a qualified person who is able to work staggered hours and to work relatively independently.
• At least 3 years of experience in flow cytometry is required, and this experience must include both sorting and analysis.  The individual should be able to work independently, and also work as part of a group where teamwork is essential.

#LI-LM1

Location: Anywhere in the US - location agnostic (all applicants need to have valid work permits in the US as current or future sponsorship will not be possible)

About People & Organizational Growth:

Roche's People & Culture organization contains six chapters, one of which is People & Organizational Growth. The P&OG Chapter enables dynamic organizations, leaders who unlock possibilities, and self authoring growth for all. We do this by focusing on organization design and development, leadership development, people development and diversity and inclusion. P&OG is organized in six Areas of Practice and four Communities.



The global Design & Curation Area of Practice will provide expertise and collaboration to design & curate cutting-edge, high impact and sustainable learning experiences for all customer segments at Roche, supporting the agile ways of working and learning and supporting Roche’s 2030 Ambitions. All Design & Curation Experts work globally and location agnostic.

Position summary

Key Activities:

• Think and act along the people development, leadership development and D&I strategies as well as the business strategies and customer needs and you actively involve, include and partner with multiple stakeholders and relevant parties from the earliest time

• Coach and mentor other experts and P&OG colleagues as required to continuously build capability in the chapter
• Participate and contribute in the P&OG Communities of your choosing

Qualifications & Experience:

You have a Master degree or comparable qualification in Human Resources, Psychology, Adult Learning, Business Administration or a related field, and you have extensive and relevant expertise in Leadership Development, People Development, Learning & Development, Organizational Development, Diversity & Inclusion or related fields in complex, global, large and matrix based organization. Your further qualifications are:

• Broad and deep knowledge and experience of agile principles and methodologies applied in an enterprise-wide context as well as instructional design expertise
• Experience with agile and technology-enabled learning and development solutions, demonstrated experience in working in and leading agile and design thinking teams
• Digital savviness and expertise in learning & development technologies and digital product development & collaboration platforms
• Proven project and stakeholder management skills in a complex and matrix environment, advanced negotiation and influencing skills and decision making competencies

• Demonstrated courage and ability to face into ambiguous situations, risk-taking and experimenting, initiating change and creating innovative solutions while questioning the status quo

• Strategic thinking skills and experience in translating strategies into learning experiences
• Proven communication skills, fluent English language skills, other languages a plus

As a member of the Corporate Communications team, the Senior Manager will drive communications programs related to diversity, equity and inclusion; philanthropy; sustainability; HR / talent attraction and retention; healthcare policy; manufacturing; and site operations. In addition to Genentech’s corporate media engagement activities, the Senior Manager will also run digital storytelling and social media programs.

The Senior Manager will interact with and advise senior leaders and work closely with functional partners within Corporate Relations (e.g., Brand, Internal, Digital) and key stakeholders throughout the company (e.g., Chief Diversity Office, Government Affairs, Legal, Human Resources, Site Services, Corporate and Employee Giving).

 

The position requires an individual who is strategic, curious, questions the status quo, solves problems and has the ability to take smart risks.

Responsibilities:

• Develop and implement external media and digital communication strategies to communicate Genentech’s corporate story and build positive brand reputation with key stakeholders.
• Maintain thorough knowledge of relevant topics including Genentech’s medicines and pipeline; diversity, equity and inclusion programs, workforce demographics; talent recruitment and retention; competitor landscape and policy/other issues impacting the business.
• Collaborate with Roche's Global Communications and Media Relations teams in Basel to ensure aligned messaging and approach.
• Serve as a media spokesperson; build and maintain relationships with key reporters.
• Act as a strategic counselor to senior management and relevant cross-functional teams.
• Manage public relations agencies that support our work.  Oversee associated budgets and resources; measure and evaluate the effectiveness of communication strategies.

Skills / Abilities:

• Broad communications experience with expertise in D&I, healthcare, corporate communications and issues management.
• Proven media relations skills with top-tier, national, and trade media, as well as an understanding of healthcare and the biotechnology/pharma business model.
• Outstanding oral, written and presentation skills.
• Results-oriented with proven track record for meeting or exceeding goals.  
• Strong consulting skills with the ability to quickly assimilate business needs and circumstances and effectively advise others. Effectively advises internal stakeholders and partners on the most strategic, high-level or complex matters  
• Outstanding time management and organizational skills. Consistently executes multiple, and sometimes competing, activities and complex projects to high quality conclusion, on time, and within-budget
• Strong customer-orientation and proven track record of collaborative work relationships.
• Demonstrates strong executive presence and has cultivated strong and trusting relationships with cross-functional partners and executive leaders
• Strong influencing and negotiation skills. Is highly skilled at influencing without authority and driving cross-functional activities to successful conclusion
• Strategic and creative approach to communication and program development.
• Bright, hardworking and enthusiastic with a proven commitment to excellence.  Self-starter with excellent interpersonal skills.  Team player.  
• Skilled in taking on new challenges, navigating ambiguity and striving for clarity/focus.  
• Proven ability to communicate concisely and translate complicated topics into lay language. 
• Understanding of evolving digital and social media technologies.

Qualifications:

6 or more years’ relevant communications experience.

Bachelor’s Degree required. Graduate or higher-level degree is a plus.

Relevant experience at a PR agency or in-house at a company is preferred.

Title: Therapeutic Area Manager (TAM), Rheumatology – Georgia Ecosystem

Territory: Savannah, GA and surrounding cities.  It is preferred the candidate lives in the Savannah or surrounding cities.  

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

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 GA 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.  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.

Therapeutic Area Manager (TAM)

Austin/ Dallas- mostly Austin area

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.

Customer Engagement Model

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.

In order to achieve our vision of delivering ever better health outcomes for patients while lowering overall healthcare costs, we are reinventing our customer engagement model. We started on this journey by listening to our customers, and learning from leaders in customer service in other industries. We learned customers are inundated with information on new treatment options. They’re overwhelmed by industry professionals vying for their time. We learned they are also focused on better outcomes at lower costs. And, we learned we are uniquely positioned to partner with many stakeholders across the healthcare system to achieve this goal.

In our new customer engagement model, we are bringing the full value of our portfolio to where healthcare is delivered - locally. No longer will a national strategy supercede local needs. 

Each ecosystem has been designed around how patients receive care across the country. The ecosystem team will work together to better understand the needs of the ecosystem and put plans in place to address the needs, as well as identify partnership opportunities to advance our shared goals. And, every leader in our new customer engagement model will add direct customer accountabilities to their leadership responsibilities. We believe this is key in maintaining our customer focus and ensuring our model adapts and flexes over time.

As a member of the ecosystem team, you will be able to fully leverage your skills and capabilities alongside the full Genentech portfolio and our rich and robust pipeline. And, the simplicity of our model allows you to do more for your customers and patients, focusing on what is needed locally while also leveraging best practices from other ecosystems.

Join us as we strive to deliver ever better health outcomes for patients, lower overall healthcare costs and reinvent customer engagement in our industry. 

Position Overview

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.

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

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.

Colorado applicants are not eligible at this time

Sobre a Roche Diagnóstica

A Roche Diagnóstica,  líder mundial em diagnósticos in vitro, dedica-se a soluções de diagnóstico laboratorial. Atuamos para oferecer produtos e serviços exclusivos, além de testes inovadores para pesquisadores, médicos, pacientes, hospitais e laboratórios.

Sobre a Posição

Responsável por promover e vender produtos para as contas-chave de grupo de saúde verticalizados no país. Atua como um consultor confiável para as principais partes interessadas da conta, se destaca no desenvolvimento, negociação e implementação de soluções adaptadas às necessidades específicas e às estratégias de negócios da conta. Desenvolve e implementa planos de contas abrangentes com base em uma compreensão completa das operações do cliente, aprimorando os níveis globais de vendas e rentabilidade em alinhamento com os objetivos do cliente. Estabelece e mantem relacionamentos de clientes em longo prazo, oferecendo um excelente atendimento ao cliente. Contribui e atinge resultados através da gestão e treinamento contínuo de seus subordinados. Possui total autonomia para tomada de decisão na gestão de funcionários, incluindo contratação, treinamento/capacitação, gestão de desempenho e ações disciplinares progressivas. Acompanha processos proativamente junto aos departamentos internos (vendas, marketing, financeiro, serviço técnico, serviço de TI e cadeia de suprimentos) como o principal ponto de contato para a conta-chave.

Sobre o seu Perfil

• Superior completo, preferencialmente em uma área científica ou relacionada; pós-graduação (por exemplo, MBA) é um diferencial;
• Vasta experiência em vendas, marketing ou operações (por exemplo, experiência de gerenciamento de contas B2B), no ambiente de saúde (diagnóstico IVD ou IVV, medical devices ou similares); A experiência em gerenciamento de grandes contas multinacionais e projetos complexos;
• Histórico de planejamento, negociação, encerramento e implementação de negócios sustentáveis com base em análises estratégicas de 360° das necessidades dos clientes; experiência com a abordagem Professional Selling Skills, Strategic Selling Coaching e Gestão do Funil de Vendas (Miller-Heiman) é um diferencial;
• Mentalidade conceitual e estratégica com excelente perspicácia comercial; sólidas habilidades analíticas e financeiras, excelentes habilidades de comunicação e apresentação verbal e escrita (português e inglês), bem como experiência de sistemas, incluindo, mas não limitado a: aplicativos do MS Office, SAP; Salesforce (ou outros sistemas financeiros e de CRM;
• Habilidade de liderar e treinar uma equipe multifuncional; excelentes habilidades sociais para gerenciar conflitos, motivar e influenciar em uma organização matricial e desenvolver relacionamentos fortes com os clientes;
• Resiliente e automotivado, impulsionado pelo desafio e aprendizagem contínua, orientação proativa em direção a resultados e decisões; capacidade de realizar diversas tarefas ao mesmo tempo e lidar com um ambiente de alta pressão com cronogramas significativos;
• Competência básica no planejamento / gerenciamento de projetos e habilidades de melhoria de processos; gerenciamento de projetos qualidade six-sigma e certificações Lean é uma vantagem.

We have an exciting opportunity for a talented medicinal chemist to join our Small Molecule Discovery Chemistry Department at Genentech in South San Francisco.  The successful candidate will be responsible for independently designing and synthesizing analogs for molecular targets during the lead identification and optimization stages as part of a drug discovery team.  This position would be a chance to contribute to cutting edge research to drug the undruggable in various disease areas as part of a highly collaborative organization.  

Qualifications: 

• Bachelor’s or Master’s degrees in chemistry

• Solid knowledge in modern synthetic organic chemistry and ability to troubleshoot chemistry challenges

• > 7 years industry experience in medicinal chemistry

• Expertise in structure and/or property-based design

• Ability to progress independently a chemical series by simultaneously optimizing multiple parameters

• Strong communication skills as candidates are expected to give a conference quality seminar during their interview and will be presenting their research in team meetings

• Highly collaborative with the desire to interact broadly with colleagues from various departments

• Genuine curiosity to learn from colleagues and to contribute to the success of a team is definitely recommended

• Good understanding of drug metabolism and pharmacokinetics concepts

• Scientific leadership skills or desire to develop such skills are a plus

#LI- BK2

We have an exciting opportunity for a talented chemist to join our Small-Molecule Drug Discovery Chemistry Department at Genentech in South San Francisco, CA. The successful candidate will be responsible for designing and synthesizing analogs for molecular targets during the lead identification and optimization stage as part of a drug discovery team.

Applicants should have 0-10 years of post PhD (Scientist) or 8-15 years (Sr. Scientist), or equivalent and relevant experience, in chemical research.

Solid knowledge in modern synthetic organic chemistry is required.

Preferred applicants will demonstrate extensive experience and record of accomplishment in one or more of the following areas: medicinal chemistry, methodology/catalysis, total synthesis, chemical biology and physical organic chemistry.

Applicants should convey strong verbal and written communication skills and an ability to work collaboratively in teams.

#LI-BK2

Genentech seeks a talented and highly motivated Bioinformatics expert to curate, process and maintain large amounts of genetic and genomics data sets from pre-clinical and clinical research enabling data access according to FAIR data standards.

The primary focus of this position is to be a foundational member of a new data management office that will provide a wide range of data management capabilities to the Genentech Research organization. Typical tasks include data acquisition, QC, transformations and processing through bioinformatic workflows. You will use existing tools where possible but are equally capable at coming up with software solutions that are addressing critical gaps in the bioinformatics data lifecycle. You will guide scientists to find the right dataset for their research questions and propose and discuss analysis options.  Additional tasks include data harmonization and curation against company or community standards, data models and ontologies.

A successful candidate will have experience with a wide range of bioinformatics data types (sequencing, imaging, proteomics) and practical experience in management of large and complex datasets.   A successful candidate will collaborate with interdisciplinary teams of Software Engineers, Curators, and Data Scientists, Computational and Bench Biologists.

 

Position: PT Integrated GMP Compliance Audit Transformation & Sustainability Lead

Main Purpose of the Position:

Develop, deploy and realize the following to drive PT GMP audit transformation & Compliance Sustainability across Roche/GNE manufacturing sites, global teams and external partners:

● Lead complex cross-functional (internal and external) programs related to the advancement of an integrated GMP auditing approach to further PT’s Compliance Sustainability and Pipeline Launch success

● Lead GMP Audit Transformation program activities for PT: set strategy and priorities; define implementation and change management approaches, engage stakeholders to influence adoption of new ways of working approaches, including technology, processes, compliance accountability & ownership, etc.

● Responsible to develop, define and deploy key strategies for furthering end-to-end, integrated GMP auditing across the PT global network and key partner organizations

● Serves as interface and key change agent within PTQE and across related ExQ, Global and Site Audit functions and groups (including strong partnership with Compliance Squad)

● Champions the “compliance mindset” and partners as a Compliance Ambassador. Role models “PTQE as a strategic partner”

● Drives PT Audit continuous improvement objectives through developing strategies for evolving auditing capabilities and maturing end-to-end compliance sustainability processes and metrics

● Assess, define, prioritize and lead GMP auditing capability-building programs across the network with the objective of creating consistency and competency; direct and evolve the Audit Certification Program (ACP) and related training delivery

● Establish and grow a network-wide “community of practice” for cGMP auditing

● Champion PT compliance digital transformation and compliance “good data citizenry”: enable the availability of reliable and consistent audit/site-self inspection and other key data (i.e., use of QCP)

● Align among PTQE, Compliance Squad, Site and global groups on integrated compliance auditing approaches

● Support integrated auditing strategies; align globally with key stakeholders

● Enable the implementation of consistent auditing/self-inspection processes and systems across regions

● Report metrics and Key Process Indicators (KPIs) for pertinent programs and projects

● Represent Roche/PTQE at Industry Interest Groups (i.e. Rx360, IPEC, ISPE, etc.), as appropriate

Job Duties/Responsibilities:

Through close internal partnering with key stakeholders in Site & External Quality/Compliance, Manufacturing, LPS/OE, PD, DIA, Affiliates and related global quality & compliance functions, and through external interactions with Experts/Consultants, external partners as well as Industry and Regulatory Groups, seek to align, implement, and continuously improve PT’s GMP compliance audit capabilities and sustainability outcomes:

● Provide expert strategic and operational insight, guidance and direction to site, global and ExQ staff engaged in GMP auditing activities (including but not limited to: Compliance Squad, site self-inspection functions, DIA, PD, etc.)

● Align vision, goals and objectives with PTQELT, Site LTs and key business partners

● Advise and enroll relevant groups on PT Audit Transformation vision, strategies and solutions

● Identify, design, and implement process and system improvements as proactive measures to improve PT’s compliance risk managementLead the harmonization of auditing and other compliance risk management approaches across the network and with Roche partners

● Monitor network performance related to auditing capabilities and outcomes; develop metrics and issue monthly metric reports for assigned projects

● Troubleshoot the resolution of auditing and identified compliance sustainability issues by fostering effective inter-site, inter-departmental and cross-functional partnerships

● Direct and participate in continuous improvement initiatives for Roche Quality Systems, as applicable

● Lead and participate in applicable business and performance review meetings

● Lead compliance-risk management focused continuous improvement efforts where applicable

● Lead related process improvement projects with internal stakeholders; execute projects and programs according to defined timelines

● As program lead, is accountable for team behaviors as described in Roche’s Core values

● Communicate and work to address issues with PTQE and Site Compliance representatives

● Notify Senior Management of potential quality or regulatory risks that may impact product quality or regulatory compliance

● Perform any other tasks as requested by Senior Management to support integrated compliance risk management & oversight activities

● Establish and delivery communication plan within the program team(s) and across the Roche network to enable awareness and alignment

● Develop training approaches, as needed, for PTQE and key partners in the areas of auditing

● Provide input to and rationale for department budget, if necessary

● Provide input to the PT Quality & Compliance Sustainability Plan and strategies for realization

● Participate in company external relations/collaborations and best practices efforts

● Keep up to date and provide expert guidance on industry best practices and external landscape

Qualifications: Education, Experience, Knowledge and Skills (Minimum Requirements)

● University degree in Chemistry/Biology/Chemical Engineering/ Biochemistry with demonstrated ability and experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience. Master’s degree or above highly desired.

● Minimum 15 years experience in Biotech/Pharmaceutical industry in related function/discipline

● Expertise in pharma cGMPs and GMP compliance auditing; site-level experience strongly preferred

● Ability to interpret and assess quality standards; extensive knowledge of PT’s quality system

● Ability to assess and provide consultation on compliance auditing and self-inspection practices with an operational end-to-end and global perspective

● Strength in establishing credibility and trust with diverse stakeholders

● Project management experience and the ability to lead complex projects

● Strong negotiation and influencing skills

● Knowledge of risk management and OE tools highly desired

● Able to travel approximately 30%

* This position is not eligible for relocation but can be based out of one of Roche Pharma network sites.

The Position

As the iNeST Genomic, Bioinformatic & Bio-specimen (GB2) Quality Manager you belong to Global Technical Development Quality in Pharma Technical Operations. More specifically, you will be part of a dedicated cross-functional team working on the development and manufacture of individualized Neoantigen Specific Therapy (iNeST) products, working very closely with external partners internationally as well as internally with stakeholders in the Clinical and Research (gRED) organizations.

In this position, you provide expertise and guidance to develop, implement and execute on a novel quality framework focusing on the neoantigen selection process. In collaboration with technical experts, you define the necessary set of quality requirements that governs activities related to Bio-specimen collection, Next Generation Sequencing (NGS) and Bioinformatic workflows. You ensure that those elements are integrated within the new Roche Pharmaceutical Quality System and are properly implemented as part of the iNeST product manufacturing process, either internally or at external contract organizations.

In this challenging role, you will:

• Drive the development, implementation and communication of the fit-     for-     purpose GB2’s Quality requirements for iNeST products and ensure cross-functional (e.g. Regulatory, Technical SMEs) alignment and coordination

• Contribute to the implementation of compliant internal Roche capabilities for GB2 activities applicable to both clinical and commercial neoantigen-specific programs

• Partner with the Individualized Therapies GB2 team and Roche Global Quality groups to ensure compliant selection and pragmatic qualification of Contract      Development & Manufacturing Organizations (CDMO) for Bio-specimen collection, NGS and bioinformatics workflow processing.

• Define and establish Quality Agreements and provide Quality oversight for selected GB2 CDMOs

• Perform quality risk assessments, develop mitigation plans, and follow-up on implementation progress

• Monitor emerging regulations globally to ensure that neoantigen selection processes maintain and gain compliance with those regulations

• Provide timely support for Health Authority interactions and author/review responses to relevant Health Authority information requests 

• Represent the quality assurance function for GB2 to external audiences, participate in industry benchmarking and networking

• Develop and maintain collaborative relations with external partner      companies, as well as with other key internal partners within Roche Pharma Development, Pharma Technical and gRED to ensure effective communication and foster positive collaborations

Who you are

You have a Bachelor’s or postgraduate degree in Life Sciences, Pharmacy or equivalent and additional qualification or certification in cGMP. You bring at least 7 years of experience in the biopharmaceutical industry and ideally have managed Quality activities across multiple quality system requirements (e.g. Pharmaceuticals and Devices, or Pharmaceutical and Diagnostic). In addition, you are familiar with Next Generation Sequencing (NGS) technology and software as a medical device (SaMD). You also have demonstrated impact in leading strategic quality activities for development programs from early stages through market launch.

You bring the following qualifications and competencies:

• Familiar with multiple sets of regulations and quality standards: cGMP, 21 CFR 820, ISO 13485, CLIA, CAP, NYSDOH, ISO 15189, ISO 62304, PIC/S, ICH, WHO…

• Strong collaboration and teamwork skills

• Excellent influencing-without-authority and negotiating skills when interacting with internal and external stakeholders at all levels within Roche worldwide operations, partner organizations and international regulatory agencies

• High flexibility and strong problem solving capabilities to meet business objectives. A ‘can-do’ attitude, with the ability to deal with ambiguity and to “think out of the box” and challenge the status quo

• Autonomous with ability to manage complex situations successfully as well as to coordinate multiple tasks and manage priorities to deliver on optimum results

• High intercultural awareness and experience in working across countries and company      cultures

• Excellent verbal and written communication skills including the ability to present both strategic objectives and tactical actions clearly and concisely

• Fluent (written and spoken) in English, German language is a strong plus.

This position may require up to 30% travel and will be based out of or South San Francisco (USA) preferably, or Basel (CH)

The Medical Science Director at Genentech puts patients and science at the center of all actions. They drive medical strategy and tactics aimed at maximizing medical progress. They collaborate to drive timely data generation and dissemination. They are expected to maintain an in-depth understanding of the medical strategy and relevant clinical and payer issues, while ensuring Genentech's partners understand key trends and shifts in the external healthcare landscape. They serve as the guardian for high standards of compliance, ethics and safety.  This role is organized within a network of experts, and therefore may at any time be performing a variety of medical activities, as needed.

Key Responsibilities for all Medical Science Directors:

In this role the Medical Directors will be required to perform one or more of the following activities depending upon areas of expertise or assignment to specific activities, molecules, or disease/therapeutic areas:

• Design, execute, and monitor medical strategies, plans and tactics spanning the lifecycle, including but not limited to:

  • clinical data generation design and management

  • thought leader interactions

  • sponsored and supported trials

  • registries, exploratory data analysis

  • publications

  • medical content creation and review

  • scientific exchange/engagement and scientific communications/collaborations

  • medical education

  • scientific congress planning and support

  • evaluate, synthesize, and visualize clinical and economic data and develop written scientific communication

  • identify access-related medical issues and opportunities

• Actively participate and contribute to relevant communities of practice

Key Accountabilities for all Medical Science Directors:  

• Depending upon areas of assignment for specific activities or molecules, disease/therapeutic areas or for the full portfolio, acting as a medical individual for relevant study design and monitoring, data interpretation, medical content development and review, scientific exchange and collaboration, clinical training and insights generation to internal stakeholders and external customers.

• Accountable for implementing strategy through medical tactics, tapping into the network of relevant expertise and insights

• Contribute medical expertise to Genentech work products and coach/mentor others as needed

• Facilitate sharing of information within, across and outside of Medical Affairs to enable medical progress

• Maintain an in-depth understanding of relevant medical strategy and clinical, patient/caregiver, payer and healthcare/market landscape

• Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions

Qualifications:

• Advanced Clinical/Science Degree Required (e.g. PharmD, PhD, etc.)

• 3-10 years of pharmaceutical/biotechnology relevant industry experience preferred - preferably in Medical Affairs or product development or is a recognized expert in the field or therapeutic area (with a minimum of 2 years’ clinical experience)  

• Strong academic/teaching background preferred

• Understanding of and/or previous experience with Phase I - III and/or Phase IV drug development  

• Considerable experience in the principles and techniques of data analysis, interpretation and clinical relevance, and medical writing

• Proven record in developing strong relationships with external constituents (therapeutic area experts, external organizations, etc.) preferred

• Proven track record of meeting or exceeding objectives and goals

Skills:

• Strong customer orientation/focus

• Ability to flex and thrive in an ambiguous environment undergoing transformational change

• Works well within teams and is effective in collaborating with others internally and externally

• Analytical and problem-solving capabilities and skills. Has demonstrated the ability to anticipate and solve problems of moderate complexity and scope e.g. evaluate, interpret and present highly complex data

• Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points

• Strong business acumen: knows the industry, key competitors, marketplace factors/dynamics

• Ability to effectively and efficiently manage multiple priorities

• Good interpersonal and influencing skills; can effectively and quickly establish rapport with all key internal/external partners and stakeholders and influence without authority

• Good negotiation skills: can drive discussions and decisions towards desired results

• Understanding of legal and regulatory considerations impacting pharma/biotech industry and ability and judgement to apply principles to daily activities

• Strong attention-to-detail

• Business travel, by air or car, is required for regular internal and external business meetings

#medicalaffairs

POSITION OVERVIEW:

At USMA, we focus on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Genentech organization, USMA has a pivotal role in bridging internal partner functions (including Research, Product Development, Commercial, and Government Affairs) and collaborating across the dynamic health ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all.

The Cross-Portfolio CMP (CP CMP) will act as the medical lead on Personalized Health Care (PHC) leading a team of direct reports and acts as a network leader and partners with senior leaders across the Genentech and Roche enterprise to ensure excellence in execution initially focusing on the Oncology PHC strategy, learning and sharing best practices, and incorporating customer insights to adapt and inform future direction.

They will develop or co-develop all cross-portfolio PHC strategies and activities for all TAs. Given that the most mature cross portfolio work is in Oncology with ongoing partnerships and collaborations and clinical studies, the preferred applicant will have Oncology expertise. Given the Oncology focus the CP CMP will be a member of the Business Unit Oncology leadership team. They will be asked on occasion to serve as an interim squad lead or Oncology Therapy Aligned CMP (or other TAs dependent on experience) or take on special assignments requiring his or her expertise (e.g ODAC steering committee).

The CP CMP will also coordinate and co-develop the strategy for all the non-Oncology PHC activities including pan-Neurology and pan-Ophthalmology in partnership with the Squads and CMPs. They will, in partnership across CMG, co-lead a Portfolio CMG Advisory Council that will consider external collaborations.

Execution of Oncology related PHC projects will be done by an Oncology team of Medical Partners directly reporting into the CP CMP. The execution of Non-Oncology related PHC projects by teams not directly reporting into the CP CMP. Decision rights on the strategy for Non-Oncology cross-portfolio PHC sits with the related therapy area CMP.

PHC and cross-portfolio activities are a Roche/Genentech wide company priority. The CP CMP role will be responsible for establishing and partnering across the Roche enterprise on above therapy area (TA) specific initiatives with a focus on Oncology. This will include establishing key partnerships with gRED, pRED, PD, GPS and PDMA. The role will both be focused on highlighting this critical work internally and enhancing Genentech’s company reputation. The CP CMP is the point of contact with other senior CMG stakeholders including the Commercial BU heads, the Portfolio Marketing Squad Lead. From a PHC perspective they are the point of contact for Global and PDMA PHC Head and partners in other Roche groups including FMI, FIH and Roche DIA.

This individual will assist in the interpretation of and pull through of data with Medical Teams in partnership across the enterprise playing an active role in strategic medical planning and providing oversight of the plans to ensure consistency across the portfolio. The Cross-Portfolio CMP will identify opportunities with impact and prioritize against the portfolio with input from the Business Unit Heads. They are expected to be a coach and strong servant leader across the enterprise to optimize functional excellence, ultimately ensuring an enhanced customer experience.

The Cross-Portfolio Chief Medical Partner (CP CMP) is a core member of Genentech’s Scientific Leadership Team and is responsible for providing deep medical insights and strategic leadership to drive scientific innovation for the company’s therapeutic portfolio focusing on Oncology. This role is pivotal in delivering cross-portfolio prioritization and has end-to-end responsibilities.

It is business critical for Genentech to make all efforts to maintain the highest of compliance standards (a three-star passport rating). This is of Global importance given Genentech’s status as the largest affiliate within the Roche Group. This role will closely partner across the enterprise, specifically with Scientific Operations and the Healthcare Compliance Office, and with Field Medical to clearly communicate the PHC strategy for partnerships .

Given the strategic and high-profile nature of this role, the CMP will also serve as a key medical spokesperson with both internal and external audiences whenever appropriate, including but not limited to the Roche/Genentech Executive Committee, the US Leadership Team, the Roche Group PHC steering committee, and as a JSC member for major PHC collaborations, regulatory bodies, industry forums, and the diverse range of customer and patient organizations.

CORE ACCOUNTABILITIES:

• Translate the corporate strategy of the company into an integrated cross-portfolio clinical strategy in partnership across CMG

• Accountable for successful strategy implementation through cross-portfolio medical tactics, tapping into the network of relevant expertise and insights

• Engage with a variety of internal and external partners and stakeholders, including scientific advisory board and other thought leaders to innovate and refine clinical product development strategies, prioritizing product opportunities and developing plans to generate evidence for clinical validation and clinical utility

• Provide medical expertise on Genentech work products and serve as a clinical resource to cross-functional teams. As a content expert, review medical and commercial documents and publications for promotional or scientific use, ensuring company compliance with regulations

• Establish relationships with thought leaders and key clinicians across the varied segments of interest to ensure Genentech has a clear understanding of customer needs and requirements as well as medical practice patterns

• Collaborate in the design and conduct of clinical studies for product validation including oversight on preparation and review of relevant written documents and oversee the identification and recruitment of principal investigators for studies

• Partner with R&D and Commercial teams to achieve optimal product design specs for diagnostic assays in development and to achieve optimal commercialization of marketed products

• Participate in life cycle management teams to speed the deployment of new products

• Interact with regulatory teams, providing medical / scientific input into regulatory submissions; assist in developing and reviewing all submissions to regulatory authorities, and represent company at key meetings

• Oversee translational efforts with partners and collaborators. Identify and provide guidance on opportunities to jointly promote data in collaboration with research and other strategic partners

• Work in conjunction with Genentech’s Market Access team to shape coverage policies

• Serve as a company spokesperson regarding clinical / medical matters. Lead company resources in addressing clinical and patient product-related inquiries

• Advocate the relevant medical perspective at the Squad level with an enterprise view and a customer-centric approach to drive medical progress

• Inform and collaborate with the medical network to execute on Squad 5-year vision, 90-day priorities, and integrated customer plan

• Partner effectively across USMA internal functions and with global (including PD, PDMA & GPS) colleagues to create and deliver options to support Squad short- and long-term goals

• Lead interactions with regulatory agencies, clinical experts, and work with cross-functional teams to design, develop and implement clinical studies and generate evidence based on customer needs and partner with members of the Squad to develop and communicate an integrated product strategy

• Responsible for enabling a customer centric culture across the medical network, prioritizing customer engagement to share insights, seek input, and identify opportunities to co-create solutions around unmet medical needs

• Serve as a mentor and coach for other Medical Partners and establish an inspiring team culture through continuous demonstration of leadership commitments

• Operate with a P&L mindset at the Squad level

• Act as a guardian for high standards of compliance, ethics and safety

• With the ecosystem leadership team, harness the collective expertise of the ecosystem team to engage effectively and compliantly across the ecosystem. Create and foster a culture that enables and requires employees at all levels to live our Operating Principles in all aspects of their work.

• Act with a P&L mindset to deliver on maximum impact opportunities and apply resources responsibly to achieve our mission.

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.

QUALIFICATIONS & EXPERIENCES:

• Physician preferred (Board Certified MD or equivalent)

• 10 or more years of pharmaceutical / biotechnology industry experience – preferably in Medical Affairs or Product Development or is a recognized expert in the field. Oncology experience is preferred given the nature of the Cross-Portfolio work.

• Strong academic background is required and drug development experience spanning all phases of research

• Experience leading entire disease area focused teams across different Therapeutic Areas, with an understanding of end-to-end activities of Medical Affairs

• Sophisticated understanding of the evolving regulatory, medical practice and economic environments impacting Roche / Genentech both globally and within the US; have a thorough understanding of US regulatory / FDA requirements

• Demonstrated ability to understand and identify the needs of patients, providers and payers through credible use of health economic outcomes research and / or real-world evidence 

• Demonstrated experience in the application of various scientific technologies into translational research strategies

• Substantive understanding and exposure to corporate legal and compliance groups, and be knowledgeable of issues related to, GCP, OIG and other guiding or controlling elements of our business

• A successful track record of collaborating, coaching and influencing outcomes in complex organizations and projects

• Previous people management experience is required with demonstrated ability to mentor and develop emerging leaders

• Strong work ethic with expectation of excellence from self and others. Must have high personal credibility and outstanding written communication skills on scientific topics

• Strong interpersonal and presentation skills, good judgment and ability to communicate with a diverse range of senior stakeholders

• Strong understanding and connectivity to regional ecosystems teams is highly preferred to ensure medical strategies address unmet medical needs within ecosystem

• Responsible for representing Genentech at key executive exchanges and fostering relationships with top tier thoughts leaders in specific disease area of expertise

• Scientific credibility and enterprise thinking on how medical affairs impacts the broader organization and ability to provide proactive solutions to complex enterprise needs

• Finance and / or large-scale budget development, management and administration experience

• Understanding and familiarity with agile ways of working

• Knowledge and experience in digital and analytics

• Business travel, by air or car, is required for regular internal and external business meetings

• Complies with all laws, regulations, policies and procedures that govern the conduct of GNE activities

#medicalaffairs

Under the direction of the Process Unit Lead, perform a wide variety of tasks and operations that are required to formulate, fill, and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility.  Troubleshoot, maintain, assemble, install, and repair all electronic, mechanical, and instrumentation devices on production equipment as required.  Assist on major equipment overhauls, repairs, and installations as necessary.  All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.

Contract for 6 months with possible extensions up to 3 years

Day shift is 5:00 am - 3:30 pm

Swing shift is 3:00 pm - 1:30 am

In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:

• Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
• Embraces Class A principles and behaviors.
• Continuously in search of ways to maintain the highest levels of productivity.
• Actively participates in a teamwork environment that maintains a high performance culture.
  
   

Responsibilities:

• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Perform safety and housekeeping audits as required.
• Set up, change over, and test run equipment for various-sized vials and packages as required.  Make mechanical and electrical adjustments necessary for the correct operation of the equipment.
• Act as a troubleshooter, moving between all areas to assist related crafts in the performance of their duties.  Diagnose problems involving electronic, electrical, instrumentation, and pneumatic hydraulic control systems.  Work with the maintenance department and/or outside services to repair, maintain, and calibrate these systems as required.
• Perform or coordinate major and minor overhauls of production equipment as needed.
• Perform training of other Operations Specialists.
• Assist in the development of plant SOP’s and training materials.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
• Assist and/or operate all sterile filling and final vial packaging equipment in the plant.  Perform material handling in the plant as required.
• Perform preparation of sterile components.
• Assist in the cleaning, set-up, sterilization, and performance of maintenance on a variety of processing equipment.
• Perform bulk thaw, dilution, and formulation operations.
• Conduct environmental monitoring activities in the manufacturing areas as required.
• Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
• At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Perform cleaning and housekeeping duties as required.

Qualifications / Requirements:

 

Proficiency in the English language – reading, writing, and communication.  Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended period of time.  In addition, all candidates must pass a vision acuity and color discrimination test.

Education:

• High school diploma or equivalent.
• Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent) is highly desirable.

Experience:

Five years recent (within the last 7 years) experience in the set-up, repair and operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers.  This experience must include equipment set-up, changeover, mechanical/electrical repairs, disassembly, and preventative maintenance.  Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.

Computers:

Must be computer literate, including ability to interface with computer systems and PLC-based logic.  Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail.  Must possess basic typing skills.

Position Responsibilities:

As a member of the Leadership Development team, this individual will bring their knowledge and experience to the mission of preparing CMG colleagues to lead successfully. By collaboratively engaging with stakeholders and partners, the Sr. Trainer assesses learning needs to determine what learner experiences will address those needs.  Responsibilities include developing and executing virtual and in-person training and learning curricula and ensuring that high quality training materials, learning resources and programs are developed and published or facilitated in line with desired business outcomes.

Examples of these programs and resources include creating and leading a workshop on challenging conversations, facilitating interactive sessions on current managerial topics such as Prioritization or Building Trust and equipping managers and employees to find and navigate through our many online resources. The individual in this position will have specific responsibility for co-leading the upskilling and ongoing education of individuals in the Peer Learning Leader Role and managing online learning vendor relationships and content.  In addition to the programs they have developed, as a member of the team, the Sr. Trainer will co-facilitate a range of department workshops.  The Sr. Trainer is also expected to lend their capabilities and energy to cross-department initiatives and projects. 

The key capabilities needed for this role include the ability to create effective learner experiences, facilitate programs virtually and in person, engage with stakeholders, collaborate well, identify learning needs, create website content and bring a learner’s mindset. 

Key Accountabilities:

• Engage leadership and establish partnerships across CMG and within T&D to determine learning and development needs based on business objectives and required performance/behaviors.

• Create, plan and implement learning solutions that drive role effectiveness for the targeted audience in partnership with internal and external teammates using a variety of modalities

• Leverage understanding of stakeholder needs, perspective and capability in creating high quality training and learning materials with the agility to adapt to a rapidly changing environment. 

• Keeps up with relevant developments in field(s) of expertise, as well as the business, and exchanges knowledge with internal and external stakeholders, in order to translate insights into practice

• Delivers training (virtual and in-person) and facilitates workshops in line with T&D standards and operational objectives, to fulfill business needs and drive effectiveness of Genentech employees.

• Creates and manages digital presence of learning materials and offerings through the development and production of website content 

• Ensure that all trainings are fully aligned with Genentech’s standards and operational objectives. Evaluate the effectiveness of the training programs and training materials.

• Collaborate with internal SMEs and external vendors to create training content and facilitation plans.  Foster cross-functional collaboration with partners outside of T&D.  

• Manage complex CMG Training & Development and/or CMG wide initiatives aligned to learning and business needs

• Complete all compliance training requirements. Reinforce with the team the importance of adhering to compliance policies. Raise questions proactively and seek advice as needed.

Incumbents in the Sr. Trainer role are expected to demonstrate a high level of leadership, impact and experience. They are expected to:

• Be involved in effective stakeholder management at many levels.

• Utilize expertise and experience to support Genentech stakeholders.

• Demonstrate ability to act with autonomy and leadership in developing and delivering training and executing stakeholder management.

• Assist with onboarding new team members and mentor CMG Training & Development employees.

Key Competencies:

• Achieving Results

  • Is goal-directed, persistent; driven to achieve objectives

  • Holds self and others accountable for results

  • Aligns behaviors to support the goals

• Communication

  • Reads verbal and non-verbal cues of others

  • Uses appropriate methods or approaches to communicate with others

  • Keeps others informed

• Decision Making

  • Thinks through problems clearly and logically

  • Gathers information necessary to make decisions

  • Makes decisions even when all information is not known

• Teamwork and Collaboration

  • Cooperates and supports colleagues to be successful

  • Provides and solicits input and information

  • Establishes and leverages relationships

• Technical and Business Expertise

  • Is acknowledged as an expert in the organization and acts as an advisor to those within and outside of CMG Training & Development

  • Understands the challenges faced by Genentech and creates programs to address the same

​Qualifications & Experience:

• Bachelor’s Degree is required

• Previous Trainer/facilitator experience is required; Instructional Design experience is preferred

• 3 or more years of work experience in biotechnology or pharmaceutical industries is required

• Previous field experience in sales or customer facing role is desirable

• Display a high degree of customer-focused sensitivity toward internal and external customers and business partners 

• Strong influencing and presentation skills 

• Proven track record in meeting or exceeding assigned objectives 

• Business travel by air or car is required for regular internal and external business meetings (once allowed by Genentech’s COVID-19 guidance)

https://www.gene.com/careers/commercial-operating-principles

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Principais Responsabilidades:

- Promove ações consultivas durante as fases de pré-venda, implementação e pós-venda das soluções de IT Roche;

- Mantém comunicação com times internacionais acerca dos produtos foco e relacionados (Suporte América Latina/GCS – Global Customer Support), bem como gerentes de produto locais, regionais e International Product Managers;

- Interage com o Coordenador de Soluções de Informação para identificar e resolver problemas com os sistemas de informação Roche;

- Oferece suporte ao campo e ao Centro de Excelência no atendimento ao Cliente Roche para as atividades de manutenção de sistemas, implementações ou integração de produtos.

- Colabora com o coordenador de Soluções de Informação na implementação da estratégia do departamento de T.I;

- Estabelece os critérios, condições e requisitos para os quais os sistemas de IT da Roche serão implementados por clientes, parceiros, representantes ou distribuidores Roche.

- Garante a segurança e implementa as melhores práticas relativas às soluções de informação.

- Mantém registro dos incidentes e das soluções propostas nos sistemas Roche (SalesForce/Rexis) dentro do tempo adequado;

- Apoio na identificação de oportunidades em clientes onde poderão se implementar projetos de RHC (Roche Healthcare Consulting);

- Garante a otimização do uso de hardware, infraestruturas, e peças de acordo com as normas locais e prerrogativas internacionais.

- Valida as comunicações com instrumentos para as interfaces de equipamentos e aplica testes a módulos de sistemas, incluindo requisitos específicos dos clientes.

- Eventualmente responsável pelas demonstrações de produto e valor agregados das soluções em clientes, feiras, congressos ou treinamentos, internos e externos.

- Dispõe-se como suporte ao processo de venda e promove as soluções de informação Roche nos clientes identificados em matérias de workflow & IT;

- Mantém com qualidade os reportes no CRM de atividades desempenhadas nos clientes ou na Roche.

Requisitos

•    Graduado ou Licenciado em Ciências da Computação, sistemas, tecnologia da informação ou cursos relacionados;

•    Análise e Desenvolvimento de Sistemas com ênfase em Gestão de projetos;

•    Pós-graduação em áreas correlatas será considerado um diferencial;

•    Perfil técnico com experiência em comunicação serial e TCP/IP;

•    Sólidos conhecimentos de T.I. focados no usuário final;

•    Conhecimentos em Protocolos de comunicação tipo ASTM, HL7 são considerados diferenciais;

•    Redes de computadores e segurança da informação;

•    Administração e manutenção de Banco de dados SQL e similares;

•    Experiência anterior em processos laboratoriais (regras de negócios para análises clínicas), LIS e Middleware serão considerados diferenciais;

•    Disponibilidade para viagens inclusive internacionais (20%,30%);

•    Disponibilidade para trabalho fora do horário comercial;

•    Inglês Avançado – Organiza, mantém e participa ativamente de reuniões internacionais;

•    Espanhol será considerado um diferencial.

Soft Skills:

•    Analítico, ágil, resolutivo e orientado ao cliente (Customer Centricity).

•    Ser capaz de trabalhar com equipe multidisciplinar, sem supervisão constante e times remotos.

•    Comunicação aberta com diferentes níveis da organização e clientes.

•    Capacidade de trabalhar sem supervisão constante e com times remotos.

You will lead and guide Genentech’s Patient and Customer Experience interdisciplinary strategy and project teams to help achieve bold and meaningful change by testing and evolving strategies and solutions that build creative capabilities for patients and customers.  As a leader and people manager of an emerging and growing function, the person in this role establishes long term vision and strategies for enhancing customer and patient experience through compelling experience design.  They will lead and oversee a team of Patient & Customer Experience Design experts inclusive of multiple Principals, Senior Managers and Project Managers within Experience Operations as well as oversee the building of the new multi million dollar co-creation lab on Genentech’s campus (The Studio).   ​In this capacity, they are responsible for stewarding capabilities, catalyzing the organization, defining omnichannel standards, and shaping and designing seamless, consistent & meaningful patient and customer experiences across CMG. Decisions made by this leader have a significant impact on the experience patients and customers have of Genentech and Roche.  They will need to engage and influence leaders at all levels around prioritization, identification of business owners, and change management.  They are responsible for ensuring that we continually listen to patient and customer feedback, co-create with them, and prioritize the highest impact opportunities across the enterprise in order to ensure patients and customers have increasingly consistent, meaningful and seamless experience with the company.

Who We Are

Experience Operations (XO) is a newly-assembled organization that brings together both emerging and established centers of excellence in patient and customer experience, engagement design, co-creation, technology platforms/systems, digital solution enablement, end-to-end content management, business activity compliance, digital and other engagement channels (web, social, mobile, relationship marketing, inside sales, samples, events, etc), and omnichannel orchestration. This combined team guides Marketing, Customer Engagement, Medical Affairs, Access & External Affairs, and all other patient- and customer-facing teams across CMG to shape and drive a seamless, consistent, meaningful, and compliant experience for patients and customers across our interactions. The team is specifically accountable to:         

• Define omnichannel standards, shape engagement strategies, and design seamless, consistent & meaningful patient and customer experiences                         

• Accelerate, connect, and enable the development of technology solutions that enhance the patient and customer experience across CMG.             

• Advance the goal of seamless, consistent & meaningful patient and customer experiences that maximize patient impact while keeping compliance at the forefront

Position Details

• Lead and guide Genentech’s Patient and  Customer Experience interdisciplinary strategy and project teams to help achieve bold and meaningful change by testing and evolving strategies and solutions that build creative capabilities for patients and customers

• Advance Genentech’s perspective on design experience through leadership and vision. We like to push the edge in all aspects of our work, and continue to build our perspective on how to activate change within organizations with a human-centered lens

• Set an enterprise-wide vision and long-term strategy for patient and customer experience design and the capabilities and operating model needed to enable our vision.

• Set standards for patient and customer experience design across all channels (in-person, virtual, digital, broadcast, etc) to create fully integrated experiences that are seamless, consistent, and meaningful

• Drive partnership and collaboration across the organization

• Hire, coach, and develop talent to lead and grow patient and customer experience design through world class capabilities

• Drive patient and customer centricity across channels and enterprise-wide touchpoints

• Lead the buildout of a multi million dollar innovation lab “The Studio” which will be the hub for innovation, co-creation and design for patients and customers

• Work loudly to celebrate and share key success                                                                                        

Leadership Responsibilities

• GROW

• LEAD                                                 

• DEPLOY

• DELIVER                                                                                                                               

This role can be remote with travel requirements.

Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as "preferred," or as a "plus," all points listed below are considered minimum requirements.    

QUALIFICATIONS & EXPERIENCE:

• Strategic leader who has created and implemented organization-wide solutions to foster growth and innovation.

• Must demonstrate multi-disciplinary experience in the pharmaceutical, biotech, financial, CPG or related industry, at least some of which was completed at the Director-level or above, e.g., marketing, sales, managed care, commercial operations, legal, finance, information technology, etc.

• Bachelor's degree (life sciences or management is a plus) required

• Related graduate-level degree is preferred

• Average of 12-15 or more years work experience

• Cross-functional, omnichannel patient and customer experience strategy

• Strong human centered and behavioral design experience required

• Voice of Customer system and Co-creation/UX design space experience preferred

• Previous experience leading function-wide business planning processes, to include development & implementation of such plans, goals and metrics

• Previous successful experience in leading teams, both in direct reporting relationships as well as cross-functional groups

• Competencies: Strategic Agility / Managing Change / Inspiring and Influencing /Technical Expertise / Communication / Achieving Results

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