The Senior CDx PL will lead the strategy and implementation of companion and clinical diagnostics for projects within Roche/Genentech’s extensive Early and Late Stage Development portfolios. Senior CDx PL will play a critical role in enabling personalized healthcare for Roche/Genentech therapeutic programs.

Responsibilities:

• Develop and lead the companion and clinical diagnostic (CDx) strategies for therapeutic programs within Genentech Research and Early Development (gRED) and Product Development (PD).
• Ensure alignment of companion and clinical diagnostic development with clinical and the overall biomarker strategy.
• Lead Joint Project Teams (JPTs) to facilitate communication across Dx partners and internal stakeholders, with the goal of ensuring alignment of critical milestones throughout the drug or product development lifecycle.
• Manage multiple CDx development partnerships and execute on jointly defined deliverables, from early planning and assay development kick-off through diagnostic approval and launch.
• Provide critical technical expertise and collaborate closely with biomarker scientists, sample operations, clinical science, clinical operations, and regulatory representatives on the successful implementation of CDx assays in clinical trials, including but not limited to patient selection, stratification, and diagnostic data collection.
• Collaborate with CDx commercial strategy colleagues to develop forward-looking strategies that enable broad access to high-quality diagnostic testing at launch.
• Provide expertise to teams and lead through complex global IVD regulatory considerations including US/EU/China.
• In collaboration with diagnostic partners, co-lead the development of diagnostic platforms, including multiplex and emerging technologies, to support investigational and approved pharmaceutical products.
• Develops disease area and/or above-molecule CDx strategies.
• Acts as the primary interface with multiple internal and external stakeholders, including for strategic diagnostic partnerships.
• Proactively identifies opportunities and collaborates on innovative approaches to CDx strategies, including process improvements impacting multiple molecules.
• Contributes to the development of new concepts/techniques/standards for CDx development across the CDx portfolio.
• Resolves complex problems and develops systems and processes that help improve department/company performance.
• May manage direct reports.

Requirements

The ideal candidate will meet the following qualifications:

• Ph.D. (preferred) in a Life Science with 7 or more years of relevant work experience, including biomarker experience, M.S. or B.S/B.A. with a minimum of 10 years of relevant work experience including biomarker experience.
• Broad knowledge and understanding of novel and established clinical and diagnostic assay technologies (e.g., IHC, ISH, Digital Pathology, NGS, PCR, liquid biopsy, MRD, soluble protein biomarkers). Experience with diagnostic assay development and/or data analysis is required.
• Understanding and experience in the drug development process (clinical trials, efficacy endpoints, biomarker testing), including experience supporting registrational clinical trials, and how diagnostic development strategy can influence drug development and commercialization, is required.
• Understanding of IVD development, including the design control process for Dx assays, regulatory considerations (including implications of IVDR), and CDx co-development is required.
• Strategic thinker, agile, and able to adapt to the evolving global regulatory landscape.
• Must be detail-oriented with strong project management and organizational skills in order to manage multiple teams, timelines, and deliverables across a variety of projects.
• Must have strong written and verbal communication skills and the ability to effectively communicate with cross-functional stakeholders and effectively manage competing priorities.
• Understanding of the CDx competitive landscape and current regulations preferred.
• Extensive experience working on cross-functional teams and closely collaborating with diverse functional stakeholders in order to meet project deliverables.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $145,200-$269,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below. Benefits

Benefits 

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.