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Sr. Administrative Associate/Management Associate

Purpose:

This position will be responsible for administrative and operational duties to support the departments of Biomedical Imaging and Molecular Biology within the Research organization of Genentech.

Responsibilities:

Administrative (~60% of time)

• Calendaring and meeting management
• Coordinate onsite and offsite events, training sessions and seminars
• Manage the interview and onboarding process of new employees
• Coordinate domestic and international travel arrangements
• Assist with managing purchasing and expense reporting
• Facilitating the day-to-day operations of multiple groups
• Additional duties include providing backup to other departmental support staff

Operational (~40% of time)

• Drafting meeting minutes
• Track progress of projects against defined timelines
• Aid in coordinating work within function

Requirements:

• High school diploma and up to 7 years of relevant work experience in demanding administrative positions, or an equivalent combination of education and experience (e.g. B.S. with ~1 year experience).
• Proactive with excellent interpersonal skills and proficient in MS Office and Google applications (gCal, gDoc, etc)
• Excellent written and verbal skills
• Strong organizational and project coordination skills with a willingness to take initiative.  Displays professionalism in all internal and external endeavors
• Successful experience indicating attention to detail, quality of work, ability to work independently and in teams, strong follow-up skills, and ability to manage multiple projects simultaneously
• Knowledge of Genentech business, organizations, guidelines, policies and systems is a plus
• Previous experience supporting or involved in science-related projects is desired

Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

The headquarters in Basel is one of Roche’s largest sites, with over 8,000 people from approximately 80 countries. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses.

The Position

The Head of Analytical Science in PT Innovation, Technology and MSAT is a strategic role to provide global leadership in the establishment and implementation of an analytical technology strategy to drive the development of novel analytical tools to realize PT’s next generation manufacturing and testing. Based in either South San Francisco, CA or Basel, Switzerland, the Head also provides strategic leadership in the collaboration with various stakeholders within and outside of PT, and external partners including suppliers, industry consortium and academic research institutions.

The scope of accountabilities includes but is not limited to the following tasks and roles:

• Leads cross functional team globally in a matrix setting to develop and implement an analytical technology strategy and roadmap for PT’s future manufacturing and testing, including areas related to analytical, bioanalytical and microbial technologies.
• Provides strategic leadership in Analytical Science to enable new technologies for integrated manufacturing and testing, including automation, miniaturization, rapid micro and online/inline analytical technologies to enable continuous process control and real time release.
• Act as a member of the PTIM leadership team. Work collaboratively as part of a team to establish priorities and direction to identify and accelerate value added innovation for PT.
• Provide the strategic leadership in the establishment of external innovation network, including collaborations with leading analytical academic institutions to assess feasibility of new technologies and guide their development for ease of implementation within a regulated environment to meet PT’s technology aspirations.

Who You Are

You’re a person who is open to new ideas and challenges conventional paradigms. For this crucial position, we are seeking a person with strong leadership skills who comes with a proven track record in building and leading successful global, cross-functional and multi-disciplinary teams in a matrix setting. The role requires an effective communicator at all levels, builds effective and constructive relationships with customers, stakeholders, partners, and team members, and demonstrates sound business acumen, change leadership and drives for innovation.

In addition, the right candidate possesses the following qualifications:

• PhD in a relevant discipline such as Science or Engineering, or an equivalent combination of education and work experience
• 20+ years of relevant experience in the industry with a minimum 8 years management experience in a global and matrix environment
• Externally recognized as an industry expert and thought leader in a related Analytical Science discipline with proven record of enabling and implementing new technologies
• In-depth knowledge of analytical sciences
• Demonstrated ability to drive for results, lead innovation and change
• Demonstrated strong oral and written communication skills
• Ability to effectively influence others across all levels of the organization
• Excellent at building and maintaining constructive and effective relationships with internal and external stakeholders
• Strong collaboration and team building across cultures, countries, technical competencies, and organizational levels

#LI-PTD-JM1

Within the Product Marketing organization, this Senior Marketing Manager will contribute and continuously develop essential marketing capabilities (eg brand positioning, content development, organized customer, digital development, channel optimization etc) and business acumen (healthcare ecosystem, customer knowledge) that enable the development and execution of the integrated product/TA value proposition. This Senior Marketing Manager will focus on Venclexta in AML and play a significant role in the development and implementation of the non-personal promotion/digital plan for Venclexta. This role will report to the Venclexta Marketing Director.

Genentech co-commercializes VENCLEXTA in the United States with Abbvie. This Senior Marketing Manager will play an essential role in our partnership with Abbvie.  In order to achieve goals, this Senior Marketing Manager will be responsible for ensuring strong alignment between both organizations and for developing and maintaining productive and professional relationships with Abbvie counterparts. 

Key Responsibilities

• Supports the development and execution of the product/TA value proposition, customer positioning, and the end-to-end customer experience while ensuring this is reflected in best-in-class digital marketing practices.

• Responsible for optimizing all marketing materials, including branding, messaging, and channel mix for target customers. Serves as a digital marketing expert when optimizing or creating new materials to address a customer need.

• Uses and commissions appropriate marketing research needed to drive the product's overall market positioning and to inform the optimal end-to end customer experience

• Identifies and works regularly with internal network partners and external resources to deliver product marketing activities.

• Responsible for ensuring a seamless, well-integrated product message and position across multiple marketing platforms.

• Accountable for high quality, compliant execution across all marketing platforms and customer types (e.g. patients, providers, organized customers)

• Prioritizes and creates personal messages and resources for field-based channels in coordination with non-personal messages and resources

• Monitors marketing activity usage, performance, and customer satisfaction to optimize campaigns and drive customer and business outcomes

• Partners with the Promotional Review Committee (PRC), including Legal and Regulatory, to ensure development, approval, and pull-through of compliant and effective promotional tactics

• Leads and/or participates in flexibly deployed work teams across the CMG network, contributing novel ideas or approaches based on their areas of expertise

• Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities

Skills and Competencies

• Strong working knowledge of all aspects of brand marketing to include positioning, branding, campaign development and channel mix

• Knowledge of the healthcare ecosystem including health economics, policy and the regulatory environment

• Knowledge of each critical customer type (e.g. patients, providers, organized customers) as well as their experiences and their needs end-to end

• Ability to think with an enterprise mindset

• Ability to influence and inspire individuals and teams across the CMG network

• Breadth of experience in product/therapeutic area, access marketing and multichannel marketing

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

• Strong customer orientation and focus

• Strong analytical skills to effectively utilize research and behavioral data to shape strategies and tactics

• Strong agency management skills

• Ability to translate strategic direction into action plan for self, and make progress in the face of ambiguity

• Good judgment in recognizing the distinction between "good enough" and perfection

• Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
• Relocation assistance being offered
• Up to 15% overnight travel

Qualifications

• Bachelors degree in Marketing / Business preferred

• MBA or other related graduate level degree preferred

Experience

• 12-15 years experience with the majority working in a product marketing function

• Experience in the managed care, pharmaceutical or biotech industry/pharmaceutical or biotech field sales

• Marketing experience in other relevant industries

• Experience in creating non-personal/digital marketing strategies, plans and tactics that have strengthened market positioning and driven high-value customer and business outcomes

Franchise: Rheumatology

Territories: New Mexico, El Paso, TX Geography includes the entire state of NM. Over night travel required.

The Clinical Specialist, Rheumatology Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent ACTEMRA IV/SC and Rituxan and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable Immunology indications.

Reports to: Division Manager, RAlly Sales

Example Duties and Responsibilities:

• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
• Works collaboratively with cross-functional teams including but not limited to managed care, thought leader liaisons, medical science liaisons.
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Understand how to use/coach to the ACE Customer Engagement Framework
• Business travel, by air or car, is regularly required

Key Competency Profile:

• Technical & Business Expertise
• Inspiring & Influencing
• Achieving Results
• Decision-Making
• Teamwork & Collaboration
• Strategic Agility

You are an individual with the following qualifications and experience:

(unless stated as "preferred" or "a plus," all other criteria is required)

• Genentech sales experience preferred
• Bachelors Degree
• Average of 4 or more years' work experience
• 2 or more years of previous sales experience in the pharmaceutical, biotech, or related industry is required
• Institutional/Hospital sales and/or disease-state experience preferred
• Proven track record of meeting or exceeding objectives & goals
• Previous experience in achieving specific sales plans or other financial targets is preferred

NOTE:

This is a remote position.

This position requires significant use of either a company provided or personal vehicle to perform 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.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

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 at https://www.gene.com/careers

#LI-COMMHC1

Patient Assistance Liaison -  Salt Lake/Denver/Las Vegas

Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

Genentech has numerous molecules in Phase I, II and III clinical trials in neuroscience disease areas including but not limited to Spinal Muscular Atrophy (SMA), Huntington’s Disease (HD), Alzheimer's and Autism.  Additional information on Genentech’s neuroscience pipeline can be found here - https://www.gene.com/medical-professionals/pipeline

Rare Diseases are common in neurology and due to the prevalence of neurological symptoms in rare diseases- of the estimated 7,000 known rare diseases that lead to significant morbidity and mortality in 25 million people in the United States, a third are thought to include a neurological component.

People with neurological rare diseases often wait for a long time for a correct diagnosis and treatment.  Although a limited number of orphan drugs are approved for neurological conditions, many orphan drugs are in development.  People living with a neurological rare disease and their caregivers are highly engaged in their treatment and with their communities via local advocacy chapters where they often attend meetings and events along with the HCPs. Our marketing team is working closely with our legal and compliance partners to ensure we are prepared to support our customers while engaging compliantly and consistent with our values. As we embark on this journey, we are seeking to build strong, customer-focused teams who will represent Genentech with integrity.

The Patient Assistance Liaison is a newly created position responsible for advocacy relations, educating patients and caregivers on the clinical profile, approved administration process, and compliantly supporting customers by minimizing patient specific access and reimbursement barriers for the continuity of care.  

The PAL works with Account Specialists and they are aligned to a shared team with shared goals, to ensure seamless geographic alignment across patients, caregivers, HCPs and advocacy to effectively address local territory needs.

PAL's provide clinical education, administration access (IT or Oral), and reimbursement expertise for patients, caregivers and HCPs when needed and builds trust in Genentech within local neurology communities prior to launch and availability of Risdiplam and RG6042 (pending FDA marketing clearance)

The PAL's compensation plan including base salary and a MBO-based quarterly bonus structure.

Front-line Customer Facing Activities

• Facilitates, staffs and attends local advocacy events; at local advocacy chapters to help create a positive, trusted, and lasting presence of Genentech in the neurology rare disease community; engages with local advocacy on programming and marketing-related sponsorships

• Provides information and educational in-services on Genentech and approved unbranded disease and, when applicable, product education to patients, caregivers and the community

• Provides clinical education to patients and works with HCP account specialist regarding in-services to HCP customers

• Provides on label patient education after the clinical decision has been made

• Communicates Payer terms, identifies and resolves on- label reimbursement issues or concerns, leverages in house support teams, as needed.

• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources

• Partners with HCP Account Specialist and may serve as a conduit between the healthcare provider and case managers to support patient access to therapy

• Assists with patient specific case management needs

• Local advocacy development – payer, office administrator, intrathecal sites and works with relevant state, institutional or other societies

• Complies with all laws, regulations and policies that govern the conduct of GNE activities and demonstrates a commitment to Genentech policies and the agile compliance philosophy

• Obtains and maintains full proficiency in disease state, product and business knowledge

• Attends and actively participates in team/region/franchise calls and meetings

• Meets administrative expectations consistently

• Communicates and aligns with field partners to determine educational opportunities and priorities

• Collaborates with home office and customer-facing representatives to align on local priorities and supports needs to achieve results and ensure effective execution

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

• Understands and adheres to HIPAA and all patient privacy policies

• Demonstrates high ethical and professional standards, and demonstrates Genentech values consistently with all customers and business

Key Competencies

The successful candidate will demonstrate the following competencies critical to this role:

• Inspiring and Influencing

• Communication

• Teamwork and Collaboration

• Achieving Results

• Technical and Business Expertise (nursing, clinical educator, relevant therapeutic area expertise; passion for patients, peers and education; customer focus)

Qualifications

• Bachelor’s Degree required

• Masters degree in Science, MBA or other related graduate-level degree is preferred

• 5 or more years work experience

• 5 or more years of clinical experience in Neurology, and/or infusion related products preferred.

• Direct to patient experience required

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

• Previous experience in Neurology therapeutic area(s) is strongly preferred

• Previous experience with both private & public payers is preferred

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

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

• Previous work or clinical specific experience in the pharmaceutical, biotech, or related

• industry is preferred

• In addition to passing Genentech's background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunizations, TB, hepatitis, and drug screening)

Success in this role will often require PALs to attend events and meetings during evenings and weekends.  This person is expected to prioritize these events and meetings in order to represent Genentech and support patients and caregivers in their communities.  While work hours are typically not to exceed 40 hours per week, flexible schedules to accommodate evening and weekend work will be operationalized.

Must live within the territory, preferably near a metropolitan area.

This position requires significant use of either a company provided or personal vehicle to perform 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.

Neurological Rare Disease Specialist -  St. Louis/Kansas City/Nebraska

Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

Genentech has numerous molecules in Phase I, II and III clinical trials in neuroscience disease areas including but not limited to Spinal Muscular Atrophy (SMA), Huntington’s Disease (HD), Alzheimer's and Autism.  Additional information on Genentech’s neuroscience pipeline can be found here - https://www.gene.com/medical-professionals/pipeline

Rare Diseases are common in neurology and due to the prevalence of neurological symptoms in rare diseases- of the estimated 7,000 known rare diseases that lead to significant morbidity and mortality in 25 million people in the United States, a third are thought to include a neurological component.

People with neurological rare diseases often wait for a long time for a correct diagnosis and treatment.  Although a limited number of orphan drugs are approved for neurological conditions, many orphan drugs are in development.  People living with a neurological rare disease and their caregivers are highly engaged in their treatment and with their communities via local advocacy chapters where they often attend meetings and events along with the HCPs. Our marketing team is working closely with our legal and compliance partners to ensure we are prepared to support our customers while engaging compliantly and consistent with our values. As we embark on this journey, we are seeking to build strong, customer-focused teams who will represent Genentech with integrity.

The Neurological Rare Disease Specialist manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, they will represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the clinical information of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Interested candidates should demonstrate the following:

• You have significant customer field experience in the pharmaceutical / biotechnology industry and have the entrepreneurial spirit and to help build our U.S. business and team.

• You have represented specialty drugs before, have product launch experience and may have specific neuroscience, rare disease and/or orphan drug experience.

• You regularly demonstrate your integrity, entrepreneurialism, nimbleness, flexibility and team spirit.

• You enjoy working in a team environment and collaborating with other business partners in the field who also support your customers.

• As an experienced field professional, you have consistently met or exceeded performance expectations and other critical business goals and metrics in a highly complex and competitive market.

• You understand payer and reimbursement landscape, and will support customers to remove access burdens for appropriate patients to receive treatment

• You have experience working with practice managers, societies and other reimbursement entities

Example Duties and Responsibilities:

• Shares on label clinical information with appropriate HCPs

• Partners effectively with Patient Assistance Liaison (PAL) to ensure positive end to end HCP, Patient, Caregiver experience

• Responsible for meeting or exceeding assigned performance goals

• Partners with PAL to effectively develop robust local geography business plans in collaboration with internal partners, as needed.

• Develops strong and long-term relationships with customers in all assigned accounts

• Participates in the development and execution of compliant, customer oriented local geography reimbursement strategies and goals to support HCPs and patients

• Works closely with PAL and Case Manager roles to proactively identify trends.

• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands

• Monitors operating costs and compliance with territory budget

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

• This role will be compensated on base salary and MBOs field IC

• Business travel, by air or car, is regularly required

Key Competency Profile:

• Technical & Business Expertise

• Inspiring & Influencing

• Achieving Results

• Decision Making

• Teamwork & Collaboration

Qualifications and Experience: unless stated as “preferred” or “a plus,” all other criteria is required

• Bachelors Degree

• 5 or more years’ customer field experience in the pharmaceutical / biotechnology industry preferred

• New product launch and reimbursement experience is strongly preferred

• Outstanding interpersonal,  presentation, influencing and negotiation skills; you have highly developed consultative selling skills and help your customers find solutions to their needs or problems

• Neuroscience, rare disease and/or orphan experience preferred

• Proven track record of meeting or exceeding objectives & goals

• Previous experience in achieving specific brand performance plans or other financial targets is preferred

• Preferred location is St. Louis, MO

NOTE:

This is a remote position that requires significant use of either a company provided or personal vehicle to perform 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.

Success in this role will often require Account Specialists to attend events and meetings during evenings and weekends. This person is expected to prioritize these events and meetings in order to represent Genentech and support patients and caregivers in their communities. While work hours are typically not to exceed 40 hours per week, flexible schedules to accommodate evening and weekend work will be operationalized.

Roche’s Personalized Healthcare (PHC) strategy aims to transform the treatment of disease and improve patient outcomes.  PHC is building capabilities for data and insight sharing, applying advanced analytics to identify new targets and biomarkers in order to enable disease area teams to accelerate clinical trials and create novel opportunities that will improve R&D productivity.  PHC is developing new methods for characterizing disease states and quantifying disease activity.  We are shaping the internal and external environment to enable value recognition from these insights.

As a key part of the PHC strategy, we are building out our capabilities and embedding them within hematology and solid tumor.  Our program will focus on at-scale multi-dimensional datasets including tissue genomics, digital pathology, as well as longitudinal radiologic imaging data and ctDNA, to develop novel, informative and early surrogate endpoints for efficacy.

In this leadership position, you will play a strategic role in Roche’s PHC transformation, driving Roche to the forefront of Oncology/Hematology meaningful data-at-scale and advanced analytics platform.  You will support the Global Oncology Head, PHC in the development of a fully functioning PHC strategy reimagines both R&D and Personalized Patient Care & Access.  These transformative efforts will require a cross-enterprise mindset which brings together both disease area and PHC strategies, as well as the ability to closely enable collaboration across the Roche organization (REDs, Pharma, DIA, Flatiron Health, Foundation Medicine, and other strategic partnerships). 

Key Accountabilities:

Hematology Franchise Leader, PHC Oncology and Hematology will be responsible for:

• Leading and managing a global cross-functional team responsible for the design and execution of a core strategy, within the overall Onc/Heme PHC program

• Driving the development of an industry-leading Oncology program focusing on data-at-scale and advanced analytics platforms.  This will include developing the strategy to leverage our internal and external assets, generating high-dimensionality, high quality patient datasets in the real-world setting.

• Driving development and delivery of the program strategy, fully aligned with and integrated into disease areas, CIT, and overall PHC strategies across R&D.   The program objectives will target the development of data and analytics capabilities, and the overall PHC platform (leveraging across and within Hematology and Oncology).

• Leading and fostering cross-enterprise internal collaboration essential to successful execution, including partnerships across Pharma, gRED, pRED, IT, Partnering, Dia, Flatiron Health, Foundation Medicine, as well as key governance committees such as CITC, LSPC, RRC.

• Developing and expanding key external strategic relationships with industry partners, public/private healthcare systems, patient advocacy, cooperative groups, payors, and other stakeholders in the PHC ecosystem, as needed to execute upon the showcase strategy.

• Ensuring coordination and alignment of key PHC capability development activities, which may include EDIS, Technology/IT platform development, data science in imaging, digital pathology, and omics, and advanced analytics and embedding within the disease areas.

• Maintain responsibility for budget, resourcing, key milestones, financial targets, and other metrics to measure results.

• Monitoring the external environment, trends, and other factors which may impact the future direction of the Oncology and Hematology PHC strategy.

• Aligning, motivating and inspiring others to work in accordance with a cross-enterprise, highly collaborative mindset, as well as mentoring and developing the next generation of PHC leaders.

  Key Qualifications

• MD required

• Experienced leader (8+ years pharmaceutical or diagnostics industry) with a record of accomplishment in strategy development, drug development, people leadership, and project execution with large, complex, cross-functional (cross-enterprise) programs/initiatives.

• Knowledge of Roche Oncology pharma business from discovery research to late stage.  Experience with CIT and core oncology disease areas is preferred.

• Strong familiarity with data science, including genomics, imaging data, digital pathology

• Science degree required.

• Critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a “big picture” innovator who can recognize possibilities and lead creative organizations.

  Key Attributes

• Demonstrated leadership in providing a strategic vision.

• Proven ability to innovate and derive actionable insights from complex data.

• Highly effective teamwork and collaboration skills that enable business results through building relationship with others both internally and externally. 

• Understanding and alignment with organizational objectives and resources to accomplish strategic objectives and financial results.

• Demonstrates energy, passion, courage, vision and the drive to be at the forefront of a changing and competitive environment for the benefit of patients, our people and the business.

• Demonstrates competence in thinking strategically, analytically and innovatively.  Able to quickly and creatively analyze and provide solutions to complex challenges.

• Commitment to developing people and promoting a culture of trust and support.

• Influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders

• English language fluency both written and oral

• Ability to travel up to 25%

#LI-PDME1

The Department of Oncology Biomarker Development (OBD) is seeking a highly motivated Scientist to contribute to the discovery and development of prognostic and predictive biomarkers to support the development of Roche/Genentech's extensive oncology portfolio.

The individual will lead biomarker research efforts supporting one or more molecules and indications to better understand mechanisms of drug action, response, and resistance.   Scope of biomarker activities will span predictive, pharmacodynamic, and prognostic biomarkers. The Scientist will be responsible for translating preclinical hypotheses into a clinical biomarker strategy and generating insights through analysis of clinical biomarker data.

Responsibilities

•    Lead biomarker strategy, execution, and analysis for clinical trials

•    Responsible for translational research to enable the development of biomarkers for use in the clinical development of our experimental medicines

•    Data analytics responsibilities will include processing and analyzing clinical trial samples, omics data analysis, and presentation

•    Publish in high quality scientific, technical, or medical journals and represent OBD externally through presentations at key internal and external meetings, advisory boards, and conferences

Requirements

•    PhD, MD or PhD/MD degree in a relevant scientific field

•    Minimum of 3 years postdoctoral basic or translational research experience in academic and/or in an industry setting

•    Preferred candidates will have experience in oncology, cancer signaling pathways, and clinical biomarker assays

•    Preferred candidates will have quantitative and bioinformatics skills in mining large scale omics data sets for clinic studies

•    Candidates must have excellent communication skills and the ability to work as part of a team with scientists and associates from multiple laboratories, disciplines and departments

Purpose:

The Clinical Trial Leader (CTL) will provide support/leadership to one or more Study Management Teams (SMTs) and/or Study Review Teams (SRTs), and provide strategic planning and organization to achieve successful study completion. The CTL will maintain full ownership of the USMA portion of a study and ensure the effective and efficient delivery of the operational aspects in accordance with the Medical Plan, The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) standards, Roche Standard Operating Procedures (SOPs), local operating guidelines and local regulatory requirements.

The CTL will  also ensure the development and maintenance of productive relationships with our customers.

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.

Role Responsibilities/Accountabilities:

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

●      Contributing clinical operations expertise into Medical Plans and study design

●      Managing assigned clinical studies operations, and assuming accountability for such, to ensure delivery of operational activities to meet Study Plans outlined in Medical Plans

●      Providing direction and/or leadership to one or more SMTs

●      Providing Contract Research Organization (CRO) and other vendor oversight

●      Ensuring assigned SMTs and vendor partners deliver on commitments to agreed targets

●      Ensuring study adherence to budget, ICH-GCP standards, Genentech/Roche SOPs and other operating guidelines and regulatory

●      requirements

●      Compliantly developing and cultivating productive relationships with external partners/stakeholders

●      Ensuring that risk and quality plans are robust, proactive and implemented for each assigned study

●      Contributing to study management and clinical operations excellence by identifying opportunities, mitigating risks and supporting

●      continuous improvement

●      Driving and making clear decisions in the project team environment

In this position, you will be responsible:

Operations:

• Serve as a member of one or more global cross-functional Study Management Teams (SMTs) and Study Review Teams(SRTs) through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the Medical Plan
• Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, and PRO specifications, drug supply and biomarker/sample management plans, TMF, and CSRs. Liaise with cross-functional team members including the SMT members to solicit input
• Draft and implement study plans, including vendor oversight, risk, quality, safety, communication
• Support EDC and Clinical Trial Management System (CTMS) systems and data maintenance
• Track budget, timelines, milestones, and critical study activities; identifying issues and proposing potential resolutions
• Partner closely with Medical colleagues to provide strategic operational input on protocol feasibility
• Provide input into the study budget and manage assigned vendor budget(s); communicate variances in actual versus forecasted spend in vendor budgets and present an action plan for resolution to the Study Management Team Leader (SMTL)
• Participate in selection of vendors (participate in the Request for Proposal [RFP] process), in collaboration with the SMTL
• Utilize outputs from operational analytical tools to enhance and improve study execution
• Oversee delegated outsourced activities to ensure Contract Research Organization (CRO) and vendor delivery against contracted scope of work.
• Contribute to study site selection and management
• Oversee protocol, country, and site feasibility assessments
• Assist with all activities related to site selection, contracting, set-up and maintenance
• Partner with Site Contracts on development of site budget template and budget negotiations
• Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
• Coordinate planning and execution of effective investigator meetings. As appropriate/applicable, drive agenda and content for investigator meetings
• Ensure accuracy and timeliness of CTMS, timeline planning tools and other core systems
• Ensure study adherence to ICH/GCP and SOPs

Other:

• Stay current on relevant therapeutic knowledge and clinical research best practices
• Participate in the evaluation of standards across one or more SMT(s)/SRT(s) with the objective of enhancing quality, productivity and efficiency
• Provide support, mentoring and study-specific training to other USMA Clinical Operations team members
• As appropriate, serve as subject matter expert on task forces, initiatives and various working groups; contributing to USMA and USMA Clinical Operations initiatives

Skills:

●      Proven track record of meeting or exceeding objectives and goals

●      Demonstrable abilities to work more independently (with less guidance and supervision) in strategizing, designing and overseeing local clinical study plans and projects

●      Strong business acumen: knows the industry, key competitors and other marketplace factors/dynamics

●      Good project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such

●      Good communication & presentation skills: communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels

●      Strong influencing & negotiation skills

●      Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams

●      Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources

●      Strong customer orientation/focus

●      Good computer skills, including common desktop programs

●      Business travel, by air or car, may be required for internal and external business meetings

Background/Experience and Education:

●      Bachelors Degree in a medical/science-related discipline

●      Strong knowledge of ICH-GCP and other relevant standards and guidelines

●      Strong knowledge of operational aspects of clinical trial management and the drug development process

●      Knowledge of relevant therapeutic areas is a plus

●      Experienced in managing aspects of one or more global, complex, clinical studies and generally experienced in clinical research/development

●      5 or more years’ proven experience in clinical research and development

●      Demonstrated experience in at least one therapeutic area relevant to the work of Genentech/Roche

●      Clinical development experience in operational aspects of conducting clinical studies, including:

●      Vendor/CRO management

●      Participating in or leading a Study Management Team

●      Implementing clinical development/medical plans

●      Coordinating study level activities to deliver data for filing or publication purposes

●      Project management experience including implementation of risk management plans and management of complex study budgets and resourcing plans

Roche’s Personalized Healthcare (PHC) strategy aims to transform the treatment of disease and improve patient outcomes.  PHC is building capabilities for data and insight sharing, applying advanced analytics to identify new targets and biomarkers in order to enable disease area teams to accelerate clinical trials and create novel opportunities that will improve R&D productivity.  PHC is developing new methods for characterizing disease states and quantifying disease activity.  We are shaping the internal and external environment to enable value recognition from these insights.

As a key part of the PHC strategy, we are building out our capabilities and embedding them within hematology and solid tumor.  Our program will focus on at-scale multi-dimensional datasets including tissue genomics, digital pathology, as well as longitudinal radiologic imaging data and ctDNA, to develop novel, informative and early surrogate endpoints for efficacy.

In this leadership position, you will play a strategic role in Roche’s PHC transformation, driving Roche to the forefront of Oncology/Hematology meaningful data-at-scale and advanced analytics platform.  You will support the Global Oncology Head, PHC in the development of a fully functioning PHC strategy reimagines both R&D and Personalized Patient Care & Access.  These transformative efforts will require a cross-enterprise mindset which brings together both disease area and PHC strategies, as well as the ability to closely enable collaboration across the Roche organization (REDs, Pharma, DIA, Flatiron Health, Foundation Medicine, and other strategic partnerships). 

Key Accountabilities:

Lung Cancer Franchise Leader, PHC Oncology and Hematology will be responsible for:

• Leading and managing a global cross-functional team responsible for the design and execution of a core strategy, within the overall Onc/Heme PHC program

• Driving the development of an industry-leading Oncology program focusing on data-at-scale and advanced analytics platforms.  This will include developing the strategy to leverage our internal and external assets, generating high-dimensionality, high quality patient datasets in the real-world setting.

• Driving development and delivery of the program strategy, fully aligned with and integrated into disease areas, CIT, and overall PHC strategies across R&D.   The program objectives will target the development of data and analytics capabilities, and the overall PHC platform (leveraging across and within Hematology and Oncology).

• Leading and fostering cross-enterprise internal collaboration essential to successful execution, including partnerships across Pharma, gRED, pRED, IT, Partnering, Dia, Flatiron Health, Foundation Medicine, as well as key governance committees such as CITC, LSPC, RRC.

• Developing and expanding key external strategic relationships with industry partners, public/private healthcare systems, patient advocacy, cooperative groups, payors, and other stakeholders in the PHC ecosystem, as needed to execute upon the showcase strategy.

• Ensuring coordination and alignment of key PHC capability development activities, which may include EDIS, Technology/IT platform development, data science in imaging, digital pathology, and omics, and advanced analytics and embedding within the disease areas.

• Maintain responsibility for budget, resourcing, key milestones, financial targets, and other metrics to measure results.

• Monitoring the external environment, trends, and other factors which may impact the future direction of the Oncology and Hematology PHC strategy.

• Aligning, motivating and inspiring others to work in accordance with a cross-enterprise, highly collaborative mindset, as well as mentoring and developing the next generation of PHC leaders.

  Key Qualifications

• MD required

• Experienced leader (8+ years pharmaceutical or diagnostics industry) with a record of accomplishment in strategy development, drug development, people leadership, and project execution with large, complex, cross-functional (cross-enterprise) programs/initiatives.

• Knowledge of Roche Oncology pharma business from discovery research to late stage.  Experience with CIT and core oncology disease areas is preferred.

• Strong familiarity with data science, including genomics, imaging data, digital pathology

• Science degree required.

• Critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs, as well as a “big picture” innovator who can recognize possibilities and lead creative organizations.

  Key Attributes

• Demonstrated leadership in providing a strategic vision.

• Proven ability to innovate and derive actionable insights from complex data.

• Highly effective teamwork and collaboration skills that enable business results through building relationship with others both internally and externally. 

• Understanding and alignment with organizational objectives and resources to accomplish strategic objectives and financial results.

• Demonstrates energy, passion, courage, vision and the drive to be at the forefront of a changing and competitive environment for the benefit of patients, our people and the business.

• Demonstrates competence in thinking strategically, analytically and innovatively.  Able to quickly and creatively analyze and provide solutions to complex challenges.

• Commitment to developing people and promoting a culture of trust and support.

• Influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external stakeholders

• English language fluency both written and oral

• Ability to travel up to 25%

#LI-PDME1

We seek a creative, highly motivated Senior Scientific Researcher to join our endeavor in basic neuroimmunology research and pursue innovative treatments for CNS diseases. The individual will use a variety of molecular, cellular, genetic, and pharmacological approaches to identify new therapeutic targets at the intersection of neurodegeneration and the innate immune system. S/he will be expected to independently design, execute and analyze experiments, and interact and communicate with other groups as part of a diverse multidisciplinary team. This is a hands-on laboratory position with abundant opportunity for collaboration with other researchers in a dynamic, fast-paced environment.

Who you are

Applicants should have a relevant PhD with a strong research background in molecular and cellular neuroscience and/or immunology. Qualified candidates will have expertise in a wide range of molecular, cellular, and biochemical techniques for understanding and manipulating biological pathways. Proficiency with primary rodent and human neural and/or immune cell cultures, including the ability to manipulate gene expression, is desired. Experience culturing human iPS-derived cell types and developing high throughput assays is a plus, though not required. A track record of answering important biological questions, overcoming challenging technical problems, and publishing research findings in high quality scientific journals is required. Critical thinking skills and an internal passion for scientific discovery are essential.

#LI-GREDES1

WHO WE ARE

The Digital Health Platforms group at Roche/Genentech is part of the R&D Personalized Healthcare (PHC) Center of Excellence building the next generation digital health platform, tools, capabilities, and products for the future of medicine. We are building a clinically validated,highly scalable and secure software platform with regulatory, quality, and privacy requirements. Our platform and services support advanced analysis of data captured and transmitted from apps, tools, Software as Medical Device (SaMDs), and connected devices.

Focused on transforming the treatment of disease and improve patient outcomes globally by bringing to bear meaningful data at scale, advanced analytics for drug development, and personalized patient care. Insights into patient and disease heterogeneity as well as clinical outcome from analysis of high- dimensionality datasets including longitudinal clinical trial and real-world datasets from large cohorts of patients, with deep characterization of individuals using techniques such as whole genome sequencing, transcriptomics, immune system profiling,anatomic and pathology imaging data, and digital approaches to continuous monitoring. This effort includes building capabilities for data and insight sharing; applying advanced analytics to identify novel targets and biomarkers to increase R&D productivity; identifying new methods for characterizing disease states and quantifying disease activity; generating insights to fundamentally change the drug development paradigm; and shaping the internal and external environment to enable value recognition from these insights.

We partner across the company with other Digital Health groups to advance digital health solutions which include hardware, software, applications, tools, and platforms to enable development of our therapies as well as more personalized care of patients across a range of therapeutic areas. We will also focus on the validation, scaling, and productization of our digital health platform, tools, capabilities, and products; along with late-stage development of novel digital biomarkers and endpoints, including the architecture, design, conduct, and analysis of analytical validation, clinical validation, and clinical utility studies to meet clinical and regulatory requirements, as appropriate.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

THE POSITION

As the Platform Validation, Regulatory, & Policy Lead part of the newly formed Platform Compliance group in Digital Health Platforms you will be a strategic leader supporting endpoint development; the validation of our digital health platform, tools, capabilities, and products; clinical validation, regulatory and policy engagement with partnership across Digital Health Platforms, Regulatory, Policy, Medical, and PCOR. You will support and lead both internal and external initiatives in our priority areas including policy, standards, and engagement with patients, clinician communities.

RESPONSIBILITIES

• Lead the clinical validation, regulatory, and policy strategy our platform, tools, capabilities, products and endpoint development towards productization.

• Define, develop, and evolve our overall digital health strategy and communication around clinical validation of endpoints and regulatory approval worldwide of our platform, tools, capabilities, and products.

• Serve as point of contact, support representation of our partner teams and the Company before regulatory authorities, including preparation of meeting agendas, materials, and minutes.

• Cross-functional reviewer on deliverables and governance closely with regulatory partners to provide strategic leadership on endpoint-related strategies for EMA and FDA, and partner with Global Access colleagues to maximize patient access to approved therapies.

• Participate and support a wide range of activities including developing conceptualmodels, hierarchical  endpoint models, endpoint reviews, scientific communications and, where required, developing, modifying and validating clinical outcome assessments(COAs).

• Support in influence the external environment by contributing to or leading precompetitive consortia such as C-Path, ISOQOL, etc.

• Support Study Planning: Provides senior strategic leadership on endpoints and strategies for evidence generation. Reviews study protocols, inputs on COA-related sections of statistical analysis plans. Act as cross-functional reviewer on strategies and deliverables.

• Analysis and Reporting: Senior strategic input/review of clinical study reports and target product profiles.

• Senior strategic oversight and input of PCOR-related content and activities e.g. manuscripts, conference abstracts/presentations.

• Support recruiting world-class talent in the Platform Compliance group in Digital Health Platforms

• Have and maintain awareness of existing and new regulations and guidance for quality, nonclinical and clinical matters, biomarkers, endpoints, and devices and advise on expectations and requirements for US and EU compliance

• Support development of strategy and assure compliance of devices including Software as a Medical Device and AI guidelines with FDA regulations and the Medical Device Directive (MDD) in the EU and other equivalent regulatory requirements at other Territories

• Support development of strategy and assure compliance of data privacy and usage with regulatory and policy requirements including GDPR

• Partner closely with key and relevant stakeholders across Digital Health Platforms, PHC Center of Excellence (CoE), Product Development Regulatory (PDR), Pharma Technical Regulatory (PTR), Patient Centered Outcomes Research (PCOR), Commercial (GPS), Pharma Partnering, and Roche Diagnostics.

• Provide technical and clinical validation advisory support and guidance for biomarker and endpoint development across all internal and external partners in digital health across Roche.

• Set clear expectations and create a positive work environment based on accountability according to our company priorities and opportunities to impact business in partnership with our measurement science, architecture & design, and compliance teams in Digital Health Platforms.

• Identify opportunities and establish strategic partnerships with leading companies and academic institutions.

MINIMUM QUALIFICATIONS

• Passionate about using technology and data-driven approaches to help improve the lives and health of our patients!

• Bachelor’s degree in Science related field; Master’s degree in Science or related preferred

• 7+ years in medical device and/or biopharma industry with regulatory and/or quality Experience

• Knowledge of ICH guidance documents and health authority regulations/standards relevant to combination products or SaMD, specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, IEC/TR 62366, ISO 13485, IEC 62304, cybersecurity, mobile medical applications, digital therapeutic, clinical decision support systems, and EU Medical Device Regulation.

• Experience in leading and securing CE-mark, 510(k), PMA, NDA, BLA, IND, CTA, Software as a Medical Device (SaMD) regulatory approvals are highly desirable.

• Demonstrated ability to plan, organize, and execute strategic initiatives to advance and drive clinical validation and endpoint strategy and development.

• Skilled in holding people accountable, establishing high standards of excellence, and stretching their abilities to perform their best work

• Strong communication, collaboration, and influence skills; able to manage ambiguity and drive outcomes in complex organizational contexts

• Able to write clear and concise documentation, excellent written and spoken communication with superb presentation skills

• Understanding of cloud platform, enterprise software and services, API integration, databases, mobile and consumer applications, device integration, and UX (Mobile, Device, and Dashboard).

• Ability to travel up to 25% time

DESIRED QUALIFICATIONS

• Experience with Quality Management Systems

• Experience with medical devices and/or Software as a Medical Device

• Familiar with Wearable and IoT Devices

PREFERRED CANDIDATE

• South San Francisco Only

• All Qualified Candidates are encouraged to apply and will be actively considered. Our talent review and succession planning process has, however, pre-identified potential candidates for this position.

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.

Roche is an equal opportunity employer.

WHO WE ARE

The Digital Health Platforms group at Roche/Genentech is part of the R&D Personalized

Healthcare (PHC) Center of Excellence building the next generation digital health platform,

tools, capabilities, and products for the future of medicine. We are building a clinically validated,

highly scalable and secure software platform with regulatory, quality, and privacy requirements.

Our platform and services support advanced analysis of data captured and transmitted from apps,

tools, Software as Medical Device (SaMDs), and connected devices.

Focused on transforming the treatment of disease and improve patient outcomes globally by

bringing to bear meaningful data at scale, advanced analytics for drug development, and

personalized patient care. Insights into patient and disease heterogeneity as well as clinical

outcome from analysis of high- dimensionality datasets including longitudinal clinical trial and

real-world datasets from large cohorts of patients, with deep characterization of individuals using

techniques such as whole genome sequencing, transcriptomics, immune system profiling,

anatomic and pathology imaging data, and digital approaches to continuous monitoring. This

effort includes building capabilities for data and insight sharing; applying advanced analytics to

identify novel targets and biomarkers to increase R&D productivity; identifying new methods for

characterizing disease states and quantifying disease activity; generating insights to

fundamentally change the drug development paradigm; and shaping the internal and external

environment to enable value recognition from these insights.

We partner across the company with other Digital Health groups to advance digital health

solutions which include hardware, software, applications, tools, and platforms to enable

development of our therapies as well as more personalized care of patients across a range of

therapeutic areas. We will also focus on the validation, scaling, and productization of our digital

health platform, tools, capabilities, and products; along with late-stage development of novel

digital biomarkers and endpoints, including the architecture, design, conduct, and analysis of

analytical validation, clinical validation, and clinical utility studies to meet clinical and

regulatory requirements, as appropriate.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology

industry for more than 40 years, using human genetic information to develop novel medicines for

serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer

& other serious illnesses. Please take this opportunity to learn about Genentech where we believe

that our employees are our most important asset & are dedicated to remaining a great place to

work.

THE POSITION

As the Global Head of Platform Compliance & Strategy for Digital Health Platforms (DHP) you

will be a strategic and key leader part of the DHP leadership team working closely to collaborate

with the therapeutic areas, other Digital Health groups across Roche, as well as Regulatory,

Policy, Medical, Technology, and other subject matter experts within the Personalized

Healthcare area and the Research and Early Development (gRED, pRED) organizations, Roche

Diagnostics, Pharma Partnering, Pharma Regulatory, Pharma Quality, Pharma Technical, PCOR,

Commercial, and Information Technology, to define and execute the strategic direction of Digital

Health to transform drug development and patient care.

RESPONSIBILITIES

• Lead the newly formed Platform Compliance & Strategy group within Digital Health

Platforms in Personalized Healthcare, Global Product Development to develop and drive

our compliance strategy for our platform, tools, capabilities, and products leveraging

industry standards in clinical validation, quality, safety, regulatory, policy, and privacy.

• Build and coach the platform compliance & strategy team to identify, lead, and maintain

end to end compliance strategy of our prioritized and approved platform, tools,

capabilities, and products through collaboration with internal stakeholders, government

and industry bodies.

• Recruit world-class talent and provide mentorship to team members

• Define, develop, and evolve our overall digital health compliance strategy and

communication on technology and data use to gain approval worldwide of our platform,

tools, capabilities, and products.

• Serve as point of contact, support representation of our partner teams and the Company

before regulatory authorities, including preparation of meeting agendas, materials, and

minutes.

• Execute US/EU regulatory project plans in collaboration with Roche's Medical Affairs,

Clinical Ops, Pharma Regulatory, Pharma Quality, Pharma Policy, and Pharma Technical

• Support the management and oversight of all operational aspects of regulatory

submissions, including maintaining timelines and developing and coordinating

submission content for various regulatory FDA, EMA and PDMA applications, safety,

amendments, and IND safety and annual reports

• Have and maintain awareness of existing and new regulations and guidance for quality,

nonclinical and clinical matters, devices and advise on expectations and requirements for

US and EU compliance

• Develop strategy and assure compliance of devices including Software as a Medical

Device and AI guidelines with FDA regulations and the Medical Device Directive

(MDD) in the EU and other equivalent regulatory requirements at other territories

• Develop strategy and assure compliance of data privacy and usage with regulatory and

policy requirements including GDPR

• Partner closely with key and relevant stakeholders across Digital Health Platforms, PHC

Center of Excellence (CoE), Research and Early Development teams (pRED and gRED),

Product Development (PD), Commercial (GPS), Pharma Technical (PT), Pharma IT, and

Roche Diagnostics.

• Set clear expectations and create a positive work environment based on accountability

according to our company priorities and opportunities to impact business in partnership

with our measurement science, architecture & design, and compliance teams in Digital

Health Platforms.

• Identify opportunities and establish strategic partnerships with leading companies and

academic institutions.

MINIMUM QUALIFICATIONS

• Passionate about using technology and data-driven approaches to help improve the lives

and health of our patients!

• Bachelor’s degree in Science, Computer Science, Mathematics, Electrical Engineering,

Information Systems or related field; Master in Business Administration, Science,

Mathematics, or Computer Science preferred

• 10+ years leading compliance efforts with thorough in depth understanding of quality,

safety, regulatory, policy, and privacy in relation to Software & Services, medical device

products.

• Knowledge of ICH guidance documents and health authority regulations/standards

relevant to combination products or SaMD, specifically 21 CFR part 4, 21 CFR part 820,

21 CFR part 803, IEC/TR 62366, ISO 13485, IEC 62304, cybersecurity, mobile medical

applications, digital therapeutic, clinical decision support systems, and EU Medical

Device Regulation.

• Experience in leading and securing CE-mark, 510(k), PMA, NDA, BLA, IND, CTA,

Software as a Medical Device (SaMD) regulatory approvals are highly desirable.

• Experience in representing products and/or interfacing with the FDA and/or EMA.

• Extensive knowledge of US FDA/EMA drug/device development process, regulations

and guidelines, including GCP

• Demonstrated ability to plan, organize, and execute strategic initiatives to advance and

drive product compliance and vision.

• Skilled in holding people accountable, establishing high standards of excellence, and

stretching their abilities to perform their best work

• Strong communication, collaboration, and influence skills; able to manage ambiguity and

drive outcomes in complex organizational contexts

• Able to write clear and concise documentation, excellent written and spoken

communication with superb presentation skills

• Deep understanding of cloud platform, enterprise software and services, API integration,

databases, mobile and consumer applications, device integration, and UX (Mobile,

Device, and Dashboard).

• Ability to travel up to 25% time

DESIRED QUALIFICATIONS

• Experience with Biomarker and Endpoint Development

• Experience with Quality Management Systems

• Experience with medical devices and/or Software as a Medical Device

• Familiar with Wearable and IoT Devices

PREFERRED CANDIDATE

• South San Francisco Only

• All Qualified Candidates are encouraged to apply and will be actively considered.  Our talent review and succession planning process has, however, pre-identified potential candidates for this position.

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.

WHO WE ARE

The Digital Health Platforms group at Roche/Genentech is part of the R&D Personalized

Healthcare (PHC) Center of Excellence building the next generation digital health platform,

tools, capabilities, and products for the future of medicine. We are building a clinically validated,

highly scalable and secure software platform with regulatory, quality, and privacy requirements.

Our platform and services support advanced analysis of data captured and transmitted from apps,

tools, Software as Medical Device (SaMDs), and connected devices.

Focused on transforming the treatment of disease and improve patient outcomes globally by

bringing to bear meaningful data at scale, advanced analytics for drug development, and

personalized patient care. Insights into patient and disease heterogeneity as well as clinical

outcome from analysis of high- dimensionality datasets including longitudinal clinical trial and

real-world datasets from large cohorts of patients, with deep characterization of individuals using

techniques such as whole genome sequencing, transcriptomics, immune system profiling,

anatomic and pathology imaging data, and digital approaches to continuous monitoring. This

effort includes building capabilities for data and insight sharing; applying advanced analytics to

identify novel targets and biomarkers to increase R&D productivity; identifying new methods for

characterizing disease states and quantifying disease activity; generating insights to

fundamentally change the drug development paradigm; and shaping the internal and external

environment to enable value recognition from these insights.

We partner across the company with other Digital Health groups to advance digital health

solutions which include hardware, software, applications, tools, and platforms to enable

development of our therapies as well as more personalized care of patients across a range of

therapeutic areas. We will also focus on the validation, scaling, and productization of our digital

health platform, tools, capabilities, and products; along with late-stage development of novel

digital biomarkers and endpoints, including the architecture, design, conduct, and analysis of

analytical validation, clinical validation, and clinical utility studies to meet clinical and

regulatory requirements, as appropriate.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology

industry for more than 40 years, using human genetic information to develop novel medicines for

serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer

& other serious illnesses. Please take this opportunity to learn about Genentech where we believe

that our employees are our most important asset & are dedicated to remaining a great place to

work.

THE POSITION

As the Distinguished Platform Architect part of the newly formed Platform Architecture and

Design group in Digital Health Platforms you will lead the overall technical architecture,

definition, and design of our platform, tools, capabilities, and products along with supporting

endpoint development. You will define and drive implementation our technology platform fitfor-

purpose on which it is easy for Digital Health Platforms group to deliver quickly safely and

sustainably our tools, capabilities, products and develop endpoints. You will closely collaborate

with the therapeutic areas, other Digital Health groups across Roche, as well as Data Science,

Advanced Analytics, Medical, Technology, and other subject matter experts within the

Personalized Healthcare area and the Research and Early Development (gRED, pRED)

organizations, Roche Diagnostics, Pharma Partnering, and Information Technology, to define

and execute the technical architecture direction of Digital Health to transform drug development

and patient care.

RESPONSIBILITIES

• Lead the architecture, design, and implementation of our technology stack and platform

fit-for-purpose on which our tools, capabilities, products and endpoint development will

be productized.

• Evaluate technology stack for our platform, tools, and products with validation, scale,

safety, and productization.

• Define overall architecture, technical requirements and deliverables to design solutions

and execute to meet our customer (scientists, clinicians, and patients) needs.

• Bring relentless drive for results and help us deliver on our vision and strategy.

• Recruit world-class talent and provide mentorship to team members in the Platform

Architecture and Design group in Digital Health Platforms

• Advance our architecture, design, and product development methodology with quality

management systems to improve, speedup validation, enhance user experience, product

and feature prioritization, and release predictability.

• Strengthen our capabilities by establishing deep expertise and experience in late stage

development of novel digital biomarkers and endpoints in collaboration with Roche's

network of internal Digital Health groups to achieve exponential value in highly

matrixed, multi-cultural global organization.

• Partner closely with key and relevant stakeholders across Digital Health Platforms, PHC

Center of Excellence (CoE), Research and Early Development teams (pRED and gRED),

Product Development (PD), Commercial (GPS), Pharma Technical (PT), Pharma IT, and

Roche Diagnostics.

• Provide technical advisory support and guidance to relevant technology, innovation, and

digital health partner groups across Roche.

• Set clear expectations and create a positive work environment based on accountability

according to our company priorities and opportunities to impact business in partnership

with our measurement science, architecture & design, and compliance teams in Digital

Health Platforms.

• Identify and iterate on our architecture, design, and development process with continuous

review of industry and technology trends along with customer feedback (clinicians,

patients, and scientists)

• Perform competitor and market trend research

• Identify opportunities and establish strategic partnerships with leading companies and

academic institutions.

MINIMUM QUALIFICATIONS

• Passionate about using technology and data-driven approaches to help improve the lives

and health of our patients!

• Bachelor’s degree in Computer Science, Mathematics, Electrical Engineering,

Information Systems or related field; PhD in Mathematics or Computer Science preferred

• 15+ years leading Software & Services technical architecture, design, and software

development in multi-disciplinary teams at the intersection of science and/or advanced

technology with a track record of shipping high scale products.

• Deep background developing enterprise micro-service architecture with progressive

experience as a leader with belief in evolutionary architecture and design for constant and

incremental change.

• Relevant experience having designed, built and maintained high volume real-time

mission critical system and have firm grasp of enterprise, cloud, and end-to-end

solutions.

• Experience with designing solutions to process and work with large data-sets in real-time

and multi-tenant or cloud agnostic environments.

• Expert knowledge of modern applications, including containers, Kubernetes, Big Data,

machine learning and deep learning techniques and tools, NoSQL databases (MongoDB,

Cassandra, etc.), messaging/stream systems (Kafka, etc.)

• Deep understanding of cloud platform, enterprise software and services, API integration,

databases, mobile and consumer applications, device integration, and UX (Mobile,

Device, and Dashboard).

• Ability to take a large, open-ended problem space and systematically break it down to

smaller, more tractable problems and then execute on solving each of those

• Strong communication, collaboration, and influence skills; able to manage ambiguity and

drive outcomes in complex organizational contexts

• Able to write clear and concise documentation, excellent written and spoken

communication with superb presentation skills

• Ability to travel up to 25% time

DESIRED QUALIFICATIONS

• Experience with Healthcare Systems and/or Pharma Industry.

• Experience with Clinical Trial Systems.

• Experience with Quality Management Systems

• Experience with medical devices and/or Software as a Medical Device

• Familiar with Wearable and IoT Devices

• Knowledge of Drug Discovery process flow.

PREFERRED CANDIDATE

• South San Francisco Only

• All Qualified Candidates are encouraged to apply and will be actively considered.  Our talent review and succession planning process has, however, pre-identified potential candidates for this position.

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.

WHO WE ARE

The Digital Health Platforms group at Roche/Genentech is part of the R&D Personalized

Healthcare (PHC) Center of Excellence building the next generation digital health platform,

tools, capabilities, and products for the future of medicine. We are building a clinically validated,

highly scalable and secure software platform with regulatory, quality, and privacy requirements.

Our platform and services support advanced analysis of data captured and transmitted from apps,

tools, Software as Medical Device (SaMDs), and connected devices.

Focused on transforming the treatment of disease and improve patient outcomes globally by

bringing to bear meaningful data at scale, advanced analytics for drug development, and

personalized patient care. Insights into patient and disease heterogeneity as well as clinical

outcome from analysis of high- dimensionality datasets including longitudinal clinical trial and

real-world datasets from large cohorts of patients, with deep characterization of individuals using

techniques such as whole genome sequencing, transcriptomics, immune system profiling,

anatomic and pathology imaging data, and digital approaches to continuous monitoring. This

effort includes building capabilities for data and insight sharing; applying advanced analytics to

identify novel targets and biomarkers to increase R&D productivity; identifying new methods for

characterizing disease states and quantifying disease activity; generating insights to

fundamentally change the drug development paradigm; and shaping the internal and external

environment to enable value recognition from these insights.

We partner across the company with other Digital Health groups to advance digital health

solutions which include hardware, software, applications, tools, and platforms to enable

development of our therapies as well as more personalized care of patients across a range of

therapeutic areas. We will also focus on the validation, scaling, and productization of our digital

health platform, tools, capabilities, and products; along with late-stage development of novel

digital biomarkers and endpoints, including the architecture, design, conduct, and analysis of

analytical validation, clinical validation, and clinical utility studies to meet clinical and

regulatory requirements, as appropriate.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology

industry for more than 40 years, using human genetic information to develop novel medicines for

serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer

& other serious illnesses. Please take this opportunity to learn about Genentech where we believe

that our employees are our most important asset & are dedicated to remaining a great place to

work.

THE POSITION

As the Global Head of Platform Product Management for Digital Health Platforms (DHP) you

will be a strategic and key leader part of the DHP leadership team working closely to collaborate

with the therapeutic areas, other Digital Health groups across Roche, as well as Data Science,

Advanced Analytics, Medical, Technology, and other subject matter experts within the

Personalized Healthcare area and the Research and Early Development (gRED, pRED)

organizations, Roche Diagnostics, Pharma Partnering, Pharma Regulatory, Pharma Technical,

Commercial, and Information Technology, to define and execute the strategic product direction

of Digital Health to transform drug development and patient care.

RESPONSIBILITIES

• Lead the newly formed technical Platform Product Management group within Digital

Health Platforms in Personalized Healthcare, Global Product Development to develop

and drive our productization strategy of our platform, tools, capabilities, and products

leveraging innovation and fit-for-purpose digital health technologies.

• Build and coach the technical platform product management team to identify, lead, and

maintain end to end productization roadmap of our prioritized and approved platform,

tools, capabilities, and products through complete product lifecycle management from

inception to shipping.

• Recruit world-class talent and provide mentorship to team members

• Define and evolve our platform, tools, capabilities, and products from strategic planning,

roadmap, design and specification, overall quality, and tactical execution.

• Advance product development methodology, policies and governance frameworks to

improve and enhance user experience, product and feature prioritization, release

predictability, quality, and velocity to support research and development of our molecules

and enable personalized patient care and access, in collaboration with the therapeutic area

teams and other Digital Health groups within Roche.

• Strengthen our capabilities by establishing deep expertise and experience in late stage

development of novel digital biomarkers and endpoints in collaboration with Roche's

network of internal Digital Health groups to achieve exponential value in highly

matrixed, multi-cultural global organization.

• Partner closely with key and relevant stakeholders across Digital Health Platforms, PHC

Center of Excellence (CoE), Research and Early Development teams (pRED and gRED),

Product Development (PD), Commercial (GPS), Pharma Technical (PT), Pharma IT, and

Roche Diagnostics.

• Set clear expectations and create a positive work environment based on accountability

according to our company priorities and opportunities to impact business in partnership

with our measurement science, architecture & design, and compliance teams in Digital

Health Platforms.

• Identify and iterate on our platform, tools, capabilities, and products with continuous

review of industry and technology trends along with customer feedback (clinicians,

patients, and scientists)

• Perform competitor and market trend research

• Identify opportunities and establish strategic partnerships with leading companies and

academic institutions.

MINIMUM QUALIFICATIONS

• Passionate about using technology and data-driven approaches to help improve the lives

and health of our patients!

• Bachelor’s degree in Computer Science, Mathematics, Electrical Engineering,

Information Systems or related field; Master in Business Administration, Mathematics, or

Computer Science preferred

• 10+ years leading Software & Services technical product management in multidisciplinary

teams at the intersection of science and/or advanced technology with a track

record of shipping products.

• End-to-end experience managing the product development life cycle with proven track

record of successfully launching new products and services.

• Demonstrated ability to plan, organize, and execute strategic initiatives to advance and

drive the product direction and vision.

• Skilled in holding people accountable, establishing high standards of excellence, and

stretching their abilities to perform their best work

• Strong communication, collaboration, and influence skills; able to manage ambiguity and

drive outcomes in complex organizational contexts

• Able to write clear and concise documentation, excellent written and spoken

communication with superb presentation skills

• Deep understanding of cloud platform, enterprise software and services, API integration,

databases, mobile and consumer applications, device integration, and UX (Mobile,

Device, and Dashboard).

• Ability to travel up to 25% time

DESIRED QUALIFICATIONS

• Experience with Healthcare Systems and/or Pharma Industry.

• Experience with Clinical Trial Systems.

• Experience with Quality Management Systems

• Experience with medical devices and/or Software as a Medical Device

• Familiar with Wearable and IoT Devices

• Knowledge of Drug Discovery process flow.

PREFERRED CANDIDATE

• South San Francisco Only

• All Qualified Candidates are encouraged to apply and will be actively considered.  Our talent review and succession planning process has, however, pre-identified potential candidates for this position.

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.

Purpose

We are looking for a senior level HR Business Partner to support the U.S. Commercial, Medical and Government Affairs (CMG) organization.  As Genentech’s market-facing organization, CMG focuses on delivering more life to patients today and fueling tomorrow’s breakthroughs.  Our operating principals are our foundation and our guide to how we behave. We follow the science, do what is best for patients no matter where it leads us, and strive to create a work place where employees feel engaged, productive and proud.

The role of the HR Business Partner in CMG is to align people strategy with business strategy in an organization that is undergoing complex transformation.

Position Overview:

The HRBP is the strategic advisor to senior leadership teams on all things People.

We provide value by:

• Interpreting the business environment and crafting a people strategy to meet the needs of the business
• Shaping and aligning strategy, culture, practices, and behavior
• Building leadership capability to ensure every employee can make meaningful progress for patients
• Optimizing our people resources through workforce planning and analytics
• Identifying strategies for attracting, retaining, and developing talent

Key Responsibilities:

• Talent retention: Create and advise on strategies to keep our best people, with the right capabilities, excited about the opportunity to add value in CMG
• Talent movement: Facilitate the movement of the right people to the right work at the right time
• Talent attraction: Define and communicate opportunities in ways that are compelling to the talent we require, both internal and external to Genentech
• Job design: Identify skills needed to address business needs, build in clear accountabilities for appropriate leveling and pricing, ensure each role is unique with explicit value
• Organizational design; Understand desired outcomes for the org unit, create roles to achieve the outcomes, organize roles to best facilitate the interaction of work, people and processes within and outside of the org structure
• Capability identification: Define skills and knowledge required to support business strategy, assess current state vs. desired future state, build a plan to move from current to future state
• Workforce planning: Assess and align resources required to meet business priorities over a defined period of time
• Employee engagement: Advise leaders on ways to create a positive employee experience, ensure employees are inspired and motivated to be successful within the culture
• Organizational health: Identify indicators that signal the degree to which people, processes, and systems are aligned to desired business outcomes and employee experience

Qualifications:

• 12 to 15 years relevant experience
• Bachelor’s Degree or equivalent work experience
• Advanced level competencies in workforce planning, leadership effectiveness, organizational design and development, talent management, and change management
• Previous HR Business Partner experience in agile organizations undergoing transformation highly preferred
• Proven track record of driving results and making impact
• Ability to function effectively in ambiguous situations
• Highly skilled in demonstrating adaptive leadership

The successful candidate will be a key member of the Media Development group within the Cell Culture department in the Pharma Technical Development (PTD) organization at the South San Francisco, CA site.

Responsibilities

• Develop chemically-defined cell culture media to meet different needs, including high-density cultures for biologics manufacturing.
• Innovate and apply advanced technologies to improve cell culture performance.
• Serve as resource for state-of-the-art practice in media development.
• Provide technical support and guidance to project teams, media preparation operations, raw material assessments, and supply chain updates.
• Foster a lean mindset and cultivate an environment of continuous improvement.
• Interface effectively within Cell Culture department and PTD, as well as with other internal organizations and external collaborators.
• Exert influence inside and outside the company through presentations, publications, and participation in meetings.

Qualifications

We are seeking candidates with strong technical and leadership capabilities. The level of the position will depend on the qualifications of the selected candidate.

• PhD in Life Sciences, Chemical Engineering or related discipline. Candidates with a BS/MS in Life Sciences, Chemical Engineering or related discipline coupled with 5+ years of relevant work experience may also be considered.
• Solid understanding of cell metabolism and tools for metabolic pathway analyses.
• Expertise in using computational methods, metabolic models, statistical design of experiments, –omics, and other current technologies to improve cell culture processes.
• Prior experience in media development for mammalian cell cultures is a plus.
• Demonstrated ability to support and drive technical projects to completion through scientific rigor and strong organization skills.
• Proven track record of working together with a highly productive and collaborative technical team.  
• Proven track record of building and maintaining strong relationships with partners, customers, and collaborators.
• Proven track record of excellent verbal and written communication through conference presentations and publications.

#LI-PTD-JM1

Within the Product Marketing organization, this Senior Marketing Manager will contribute and continuously develop essential marketing capabilities (eg brand positioning, content development, organized customer, digital development, channel optimization etc) and business acumen (healthcare ecosystem, customer knowledge) that enable the development and execution of the integrated product/TA value proposition. This Senior Marketing Manager will focus on Venclexta in AML and report to the Venclexta Marketing Director.

Genentech co-commercializes VENCLEXTA in the United States with Abbvie. This Senior Marketing Manager will play an essential role in our partnership with Abbvie.  In order to achieve goals, this Senior Marketing Manager will be responsible for ensuring strong alignment between both organizations and for developing and maintaining productive and professional relationships with Abbvie counterparts. 

Key Responsibilities

• Supports the development and execution of the product/TA value proposition, customer positioning, and the end-to-end customer experience.

• Responsible for optimizing all marketing materials, including branding, messaging, and channel mix for target customers. Creates new materials when necessary to address a customer need.

• Uses and commissions appropriate marketing research needed to drive the product's overall market positioning and to inform the optimal end-to end customer experience

• Identifies and works regularly with internal network partners and external resources to deliver product marketing activities.

• Responsible for ensuring a seamless, well-integrated product message and position across multiple marketing platforms.

• Accountable for high quality, compliant execution across all marketing platforms and customer types (e.g. patients, providers, organized customers)

• Prioritizes and creates personal messages and resources for field-based channels in coordination with non-personal messages and resources

• Monitors marketing activity usage, performance, and customer satisfaction to optimize campaigns and drive customer and business outcomes

• Partners with the Promotional Review Committee (PRC), including Legal and Regulatory, to ensure development, approval, and pull-through of compliant and effective promotional tactics

• Leads and/or participates in flexibly deployed work teams across the CMG network, contributing novel ideas or approaches based on their areas of expertise

• Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities

Skills and Competencies

• Strong working knowledge of all aspects of brand marketing to include positioning, branding, campaign development and channel mix

• Knowledge of the healthcare ecosystem including health economics, policy and the regulatory environment

• Knowledge of each critical customer type (e.g. patients, providers, organized customers) as well as their experiences and their needs end-to end

• Ability to think with an enterprise mindset

• Ability to influence and inspire individuals and teams across the CMG network

• Breadth of experience in product/therapeutic area, access marketing and multichannel marketing

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

• Strong customer orientation and focus

• Strong analytical skills to effectively utilize research and behavioral data to shape strategies and tactics

• Strong agency management skills

• Ability to translate strategic direction into action plan for self, and make progress in the face of ambiguity

• Good judgment in recognizing the distinction between "good enough" and perfection

• Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
• Relocation assistance being offered
• Up to 15% overnight travel

Qualifications

• Bachelors degree in Marketing / Business preferred

• MBA or other related graduate level degree preferred

Experience

• 12-15 years experience with the majority working in a product marketing function

• Experience in the managed care, pharmaceutical or biotech industry/pharmaceutical or biotech field sales

• Marketing experience in other relevant industries

• Experience in creating marketing strategies, plans and tactics that have strengthened market positioning and driven high-value customer and business outcomes

The Individual Contributor in Market Analysis and Strategy (MA&S) is a strategic thought partner to key stakeholders and an integral contributor to Genentech’s commercial planning efforts. 

He/she is responsible for providing competitive and strategic insights across CMG (Genentech Commercial, Medical and Government Affairs organizations) with minimal to moderate guidance / supervision, leveraging their capabilities in the following area of expertise:

• Competitive Intelligence: monitoring and tracking competitive landscape including competitor clinical and commercial activities; conducting threat assessment (including timelines and probability of launch assessments), partnering with key Genentech cross-functional partners to align on implications for the GNE portfolio

While the role requires Competitive Intelligence capabilities, all Individual contributors have the opportunity to blend and extend their expertise on different initiatives to further develop both the breadth and depth of their capabilities.

MAJOR RESPONSIBILITIES

• Work with Team Leads (TLs) and Franchise Leads (FLs) to understand business needs and priorities, as well as immediate scope of work
• Use market and product understanding to inform research approaches
• Provide an objective commercial viewpoint based on in-depth understanding and analysis of commercial, clinical, and scientific competitive information (includes attendance and coverage of key medical conferences)
• Understand competitor profiles and drivers to develop competitive strategies 
• Lead competitive threat assessments to develop rigorous team assumptions about key competitors; lead CI communications (alerts) to inform the organization about key competitive events and implications to GNE, provide situational analysis support for quarterly business reviews, brand planning, launch or competitor readiness reviews, etc. 
• Collaborate within cross-functional teams to develop solutions, gain alignment and deliver impactful business insights; engage necessary stakeholders to enable better decision-making
• Openly share perspective and insights to elevate team thinking and drive a balanced, holistic point of view; effectively weigh and communicate trade-off considerations
• Take an enterprise mindset, linking individual responsibilities with broader organization; focus on outcomes that provide most business value
• Demonstrate self-accountability
• Look for opportunities for continuous improvement; engage managers and peer group regularly for coaching, assistance, and advocacy
• Act as a thought partner and advisor to all relevant teams and stakeholders; look for and establish opportunities for peer mentorship

WHO YOU ARE

In Individual Contributors, we are looking for people who are nimble, able to effectively collaborate and lend expertise to multi-functional teams and adapt quickly to competing priorities within their Franchise. We are also looking for people who are committed to continuing to make Genentech a great place to work, by seeking opportunities to develop their own and others’ expertise through ongoing mentorship and coaching.

• "Self-starter"; strong sense of responsibility with demonstrable comfort in an entrepreneurial environment 
• Able to work effectively in a fluid, cross-functional matrixed environment and stand out as a successful collaborator 
• Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships 
• Good problem-solving ability, breaking down complex problems into distinct parts, managing uncertainty, understanding, anticipating interdependencies 
• Able to proactively “connect the dots” by asking thought-provoking questions 
• Objective when presenting insights and guiding decision-making; demonstrate good presentation skills by pairing sound analytics with storytelling
• Motivated to continuously improve performance; outcomes-focused and driven to achieve objectives
• Able to lean in and manage through change

PREFERRED QUALIFICATIONS

• Bachelor’s Degree (Business, Economics, Statistics, Mathematics, or Physical Sciences or related field is a plus); MBA or Graduate-level Degree is preferred
• Two to five years work experience, preferably within pharmaceutical or biotech industry (commercial or clinical) and/or management consulting
• Undergraduate or graduate work in life sciences; advanced degree in business or science preferred
• Competitive intelligence experience preferred
• Exposure to pharmaceutical product development is a plus
• Experience acting as a strategic thought partner to teams; Demonstrated ability to problem solve and think outside the box
• Proven track record of leadership, time-management, project management, and teamwork 
• Expertise in standard analysis and presentation software (Excel, PowerPoint) 
• Persuasive written and verbal communication skills
• Strong attention to detail 
• Experience managing outside vendors preferred 

This role leads a team of direct reports including Technical Managers, Engineers, and Specialists in the Maintenance and Calibration group.  In addition to team leadership, the role provides technical support. The role is accountable to ensure the maintenance and calibration aspects of the project portfolio are realized; ensure compliance of the maintenance and calibration programs; ensure vendor budget is met; provide investigation and complex discrepancy support; and drive maintenance and calibration continuous improvement efforts; and provide skills and training necessary to ensure a broad base of knowledge within the Maintenance and Calibration teams.

Responsibilities

• Supervise technical managers, engineers, specialists and on-site service providers; ensure daily productivity by establishing priorities and resource utilization

• Represent Maintenance and Calibration at meetings and report department progress and communicate department needs

• Provide purchasing oversight for maintenance and calibration vendor activities with budgetary adherence responsibility

• Represent Facilities on project portfolio teams and supervise personnel who perform the same duties

• Compliance of the maintenance and calibration program

• Identify efficiencies to external contract budget

• Represent Facilities on complex Quality records and oversee personnel who perform the same duties

• Provide technical expertise to support staff and oversee troubleshooting and repair of equipment failures as necessary

• Ensure that all repair and maintenance activities are conducted in accordance with written cGMP procedures

• Revise old or establish new procedures for the Preventive Maintenance program to meet cGMP requirements

• Provide status updates and business fundamental reports to management as required

• Evaluate employee’s customer service, professionalism and technical abilities and provide feedback as necessary

• Collect and organize technical data from equipment manufacturers, equipment users, and engineering personnel

• Provide training to co-workers, to ensure a broad base of knowledge and minimize specialization within the group

• Review and approve all time sheets for staff where applicable

• Identify and evaluate organizational relationships between execution groups and engineering groups and contractors

• Develop, evaluate and take action on facilities benchmarking studies.

• Establish and enforce project management policies and procedures

• Represent the Facilities department in making commitments on the part of the Company to representatives of the local, State, and Federal regulatory agencies

Qualifications

• Bachelor’s degree or equivalent combination of education and experience

• 8+ years of relevant technical experience

• 3+ years of experience in a supervisory role

• Ability to lead and communicate, and be able to work with other people in the organization to accomplish common departmental and corporate goals

• Must be organized and flexible, capable of working on multiple tasks with changing priorities

• Ability to supervise maintenance/calibration staff and coordinate department activities

• Ability to interact with internal and external customers including vendors and other departments and individuals to provide information, documentation or answer questions

• Ability to mentor and coach subordinates and develop career plans for employees

• Ability to read and interpret engineering (mechanical/electrical/P&ID) drawings and specifications preferred

• Experience working in a cGMP or equivalent environment