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As a senior leader within Translational Medicine’s Scientific Operations, Diagnostics Development and Technology (TM-ODT) function, the Director of CDx and Clinical Platform Development is responsible for architecting the long-term vision and operational framework across three foundational pillars: Companion Diagnostic (CDx) Development, Clinical Platform Development, and Biomarker Policy Innovation. In this role, the leader ensures deep strategic alignment with key partner functions within Pharma - such as Biomarker Science, Clinical Science, Regulatory, Commercial, Medical Affairs, Policy, and Clinical and Biomarker Operations - as well as Diagnostic partners such as Roche Diagnostics and Foundation Medicine. By leveraging technical and scientific advancements to advance the therapeutic pipeline, this position ensures that Roche/GNE maintains its position at the global forefront of precision medicine and patient-focused translational research.
The Opportunity:
As an integral member of our dynamic team, you will be able to provide:
Strategic Vision and Leadership Impact
Formulate and implement an overarching diagnostic co-development strategy to expedite the progression of the Roche/Genentech therapeutic pipeline from early-stage development through to global regulatory approvals.
Develop and oversee key strategic partnerships with both internal and external diagnostic collaborators, ensuring clinical platform developments activities align with future clinical and scientific requirements.
Promote an environment of scientific rigor and forward-looking strategy, developing a robust, top-tier team equipped to handle the intricacies of both standard (such as IHC, PCR, NGS) and emerging (such as advanced liquid biopsy, digital pathology, and multi-omic assays) diagnostic assay and clinical platform development.
Enhance cross-functional alignment by acting as a primary interface connecting Translational Medicine (TM) with Roche Diagnostics and Foundation Medicine (FMI).
Cultivate and manage critical strategic alliances with internal and external regulatory and policy collaborators, ensuring the successful translation of biomarker innovations into future policy frameworks.
COMMUNICATION / INTERACTION
Collaborates strategically with VPs/SVP of Translational Medicine, TM Disease Area Leaders (DALs), Translational Medicine Subteam Leaders (TMSTLs), gRED, PD, Regulatory, Commercial, Medical Affairs, Roche Diagnostics, Foundation Medicine, and external collaborators to guide molecule and above-molecule development strategies for CDx development, Clinical Platform development and Biomarker-based Regulatory Policy Innovation.
Maintains a robust and collaborative partnership with the pRED CDx development group, as well as pRED’s biomarker and technology focused functions.
Connects with external stakeholders, such as regulatory policy consortia, Health Authorities and TAEs in order to drive novel pathways for biomarker innovation at the portfolio and/or disease area level.
LEADERSHIP / MANAGEMENT / SUPERVISION
Manage and mentor a team of 6–8 scientific professionals, assuming full accountability for talent acquisition, retention, and proactive succession planning.
Define unit priorities, operational blueprints, and internal budgets, ensuring efficient resource deployment across molecular programs and strategic campaigns.
Foster an inclusive culture of scientific excellence, supporting team members in resolving matrixed challenges and optimizing complex priority workflows.
TEAMWORK AND INTERACTION
Drives a high-performing, collaborative team culture while actively encouraging cross-functional knowledge sharing and alignment.
Establishes robust, trust-driven alliances across multi-functional groups including Clinical Science, Commercial, Regulatory, Medical Affairs, Clinical Operations, Biomarker Operations, TM, Roche Diagnostics, and Foundation Medicine.
Collaborates closely with leadership in gRED BOMs and PD BOMs (Biomarker Operations Managers) to bridge clinical platform and diagnostic development with operational execution seamlessly across both early and late-stage programs.
Navigate enterprise boundaries to cultivate productive engagements with internal and external partners, exerting influence across all organizational levels.
Who You Are
Bachelor of Science (BS) degree in life sciences, biomedical engineering, or a related bioscience field is required (advanced degree is preferred) with 12–15 years of professional experience within the biotech, pharma, or diagnostics sectors; 5+ years of experience in CDx or IVD development; 3+ years of people leadership experience overseeing scientific professionals in a matrixed corporate environment.
Deep understanding of CDx, IVD, and clinical platform development, covering assay design, analytical/clinical validation, bridging approaches, and regulatory pathways such as FDA PMA/IDE, EMA IVDR, and China NMPA.
Extensive familiarity with both established diagnostic and emerging clinical platforms, including IHC, PCR, NGS, liquid biopsy, digital pathology, multi-omic assays.
Thorough grasp of the drug development lifecycle, including clinical trial designs, endpoints, coupled with an understanding of how diagnostic approaches impact commercialization and drug development.
Knowledge of external regulatory policy, including consortium leadership, public comment procedures, and Health Authority engagement methods.
Demonstrated experience interacting with global Health Authorities (such as the FDA and EMA) on IVD/CDx regulatory issues.
Preferred:
Prior background in regulatory science, consortia leadership, or external policy influence.
Experience regarding diagnostic product rollouts, market access trends, test reimbursement, and clinical guidelines.
Relocation benefits are available for this posting.
The expected salary range for this position based on the primary location of California is $189,300 - $351,500 Annual. 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
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Skills Required
- Bachelor of Science degree in life sciences, biomedical engineering, or a related bioscience field
- 12–15 years of professional experience in biotechnology, pharmaceuticals, or diagnostics
- At least 5 years of experience in companion diagnostic or in vitro diagnostic development
- At least 3 years of people leadership experience overseeing scientific professionals in a matrixed corporate environment
- Deep understanding of companion diagnostics, in vitro diagnostics, and clinical platform development, including assay design, analytical and clinical validation, bridging approaches, and regulatory pathways
- Familiarity with IHC, PCR, NGS, liquid biopsy, digital pathology, and multi-omic assays
- Understanding of the drug development lifecycle, clinical trial designs, endpoints, and the impact of diagnostics on commercialization and drug development
- Knowledge of external regulatory policy, consortium leadership, public comment procedures, and Health Authority engagement
- Experience interacting with global Health Authorities, including the FDA and EMA, on IVD or companion diagnostic regulatory issues
- Advanced degree in a relevant field
- Background in regulatory science, consortia leadership, or external policy influence
- Experience with diagnostic product rollouts, market access trends, test reimbursement, and clinical guidelines
Genentech Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.
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Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
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Retirement Support — Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
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Leave & Time Off Breadth — Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.
Genentech Insights
What We Do
Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.
