Director, CDx & Clinical Platform Development

Genentech • Daly City, CA

1d • $189,300 - $351,500

About The Position

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.

Requirements

• Bachelor of Science (BS) degree in life sciences, biomedical engineering, or a related bioscience field is required
• 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.

Nice To Haves

• advanced degree is 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Benefits

• Relocation benefits are available for this posting.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior