Director, CDx & Clinical Platform Development

Genentech; South San Francisco (CA); On-site; USD 189,000 - 352,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech seeks an executive leader to architect and drive the long-term CDx and clinical platform strategy for Translational Medicine. You will partner with internal and external teams to advance diagnostic co-development, regulatory alignment, and biomarker innovation across the Roche/Genentech ecosystem.

You will lead a 6–8 person team, manage budgets, and ensure rigorous scientific execution across IHC, PCR, NGS and emerging assays. California location; relocation benefits available.

Qualifications

• Bachelor of Science in life sciences or related field; advanced degree preferred.
• 12–15 years of professional experience in biotech/pharma/diagnostics.
• 5+ years in CDx or IVD development; 3+ years in people leadership.

Responsibilities

• Formulate and implement an overarching diagnostic co-development strategy.
• Develop partnerships with diagnostic collaborators and align clinical platform activities.
• Lead a high-caliber team across CDx and clinical platform development.
• Collaborate with Regulatory, Medical Affairs and external partners to influence policy.
• Coordinate with Roche Diagnostics and Foundation Medicine to align product development.

Skills

CDx development

Clinical platform development

Biomarker policy innovation

Regulatory engagement

Leadership and people management

Cross-functional collaboration

Education

BS in life sciences or related field

Advanced degree preferred

12–15 years in biotech/pharma/diagnostics

Job description

The Position

We advance science so that we all have more time with the people we love.

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.