Senior Director, Clinical Diagnostics
Job Summary
Leading the strategy for companion diagnostics in a remote full-time capacity, the Senior Director, Clinical Diagnostics will drive execution across therapeutic programs, ensuring integration with clinical development and regulatory objectives while managing a team of diagnostic professionals.
Key responsibilities
- Set and lead global companion diagnostics strategy, integrating diagnostic plans with clinical development and regulatory requirements
- Translate biomarker biology and clinical utility considerations into diagnostic target product profiles across various platforms
- Provide executive oversight of external IVD sponsors and ensure operational readiness of CDx testing in clinical trials
Required qualifications
- Advanced degree (PhD, MD, MD/PhD, or equivalent) in a relevant scientific discipline
- 12+ years of experience in companion diagnostics, IVD development, or translational medicine with progressive leadership responsibility
- Demonstrated success in leading CDx strategies through clinical development and regulatory submission
- Deep expertise in assay development and clinical validation
- Strong knowledge of global CDx regulatory pathways and experience managing external diagnostic partners
Complete Job Description
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