Director, CDx & Clinical Platform Development

About the role

Roche is looking for a Director of CDx and Clinical Platform Development within Translational Medicine's Scientific Operations, Diagnostics Development and Technology (TM-ODT) function. The role architects the long-term vision and operational framework across Companion Diagnostic (CDx) Development, Clinical Platform Development and Biomarker Policy Innovation, aligning with partner functions in Pharma and with Roche Diagnostics and Foundation Medicine.

Key responsibilities

• Formulate and implement an overarching diagnostic co-development strategy to move the Roche/Genentech therapeutic pipeline from early-stage development through global regulatory approval
• Develop and oversee strategic partnerships with internal and external diagnostic collaborators
• Build a team capable of handling standard (IHC, PCR, NGS) and emerging (liquid biopsy, digital pathology, multi-omic assays) diagnostic assays and clinical platforms
• Act as the main interface between Translational Medicine and Roche Diagnostics and Foundation Medicine
• Cultivate alliances with regulatory and policy collaborators to turn biomarker innovations into policy frameworks
• Work with VPs/SVPs, TM leaders, Regulatory, Commercial, Medical Affairs and others to guide molecule and above-molecule development strategies
• Manage and mentor a team of 6-8 scientific professionals, including talent acquisition, retention and succession planning
• Define unit priorities, operational plans and internal budgets, and foster collaboration across Clinical Science, Regulatory, Medical Affairs, Clinical Operations and others

Required profile

• Bachelor of Science in life sciences, biomedical engineering or a related field (advanced degree preferred)
• 12-15 years of professional experience in biotech, pharma or diagnostics
• 5+ years in CDx or IVD development
• 3+ years of people leadership experience in a matrixed corporate environment
• Experience engaging global Health Authorities (FDA, EMA) on IVD/CDx regulatory issues

Required skills

• Deep understanding of CDx, IVD and clinical platform development, including assay design, analytical/clinical validation, bridging and regulatory pathways (FDA PMA/IDE, EMA IVDR, China NMPA)
• Familiarity with IHC, PCR, NGS, liquid biopsy, digital pathology and multi-omic assays
• Knowledge of the drug development lifecycle and how diagnostics affect commercialization
• Preferred: regulatory science, consortia leadership or policy influence background, and experience with diagnostic rollouts, market access, reimbursement and clinical guidelines

What we offer

• Salary range of $189,300-$351,500 per year (California), with a possible discretionary annual bonus
• Relocation benefits available