Director, CDx & Clinical Platform Strategy

Roche

South San Francisco (CA)

On-site

USD 189,000 - 352,000

Full time

14 days+
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Benefits offered by this job

Relocation benefits

Job summary

Genentech seeks a visionary senior leader to architect the long-term strategy for CDx and Clinical Platform Development within Translational Medicine. You will align Roche Diagnostics and Foundation Medicine partnerships, directing biomarker and diagnostic platform programs from discovery through regulatory readiness.

You will mentor a team of 6–8 professionals, build cross-functional alliances, and drive policy-influencing initiatives while maintaining scientific excellence and programmatic

Qualifications

  • Bachelor of Science in life sciences, biomedical engineering, or related field; advanced degree preferred.
  • 12–15 years of biotech/pharma/diagnostics experience; 5+ years in CDx/IVD development; 3+ years leading scientific teams.
  • Extensive familiarity with CDx/IVD regulatory paths (FDA PMA/IDE, EMA IVDR, NMPA).

Responsibilities

  • Define and implement a diagnostic co-development strategy aligning with Roche/Genentech pipeline.
  • Lead strategic partnerships with internal and external diagnostic collaborators.
  • Develop and manage a high-caliber team across diagnostic and platform development.
  • Interface with Regulatory and Policy teams to influence biomarker policy.

Skills

CDx development
IVD development
Regulatory knowledge
Leadership
Biomarker strategy
Clinical platform development
Cross-functional collaboration
FDA EMA engagement

Education

BS in life sciences
MS/PhD preferred

Tools

IHC
PCR
NGS
Liquid biopsy
Digital pathology
Multi-omic assays

Job description

Genentech seeks a visionary senior leader to architect the long-term strategy for CDx and Clinical Platform Development within Translational Medicine. You will align Roche Diagnostics and Foundation Medicine partnerships, directing biomarker and diagnostic platform programs from discovery through regulatory readiness.

You will mentor a team of 6–8 professionals, build cross-functional alliances, and drive policy-influencing initiatives while maintaining scientific excellence and programmatic

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