Remote Senior Director, Precision Diagnostics Strategy
Regeneron Pharmaceuticals, Inc.
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Job summary
Regeneron Pharmaceuticals, Inc. seeks a Senior Director to set strategy and drive execution across a portfolio of companion diagnostics (CDx) programs.
You will lead a team of diagnostic professionals and align diagnostic plans with clinical development, regulatory submissions, launch readiness, and patient access objectives. You will translate biomarker hypotheses into fit-for-purpose diagnostic plans, define assay strategies, and influence cross-functional partners including translational
Qualifications
- Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline.
- 12+ years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine with progressive leadership responsibility.
- Demonstrated success leading CDx or biomarker-enabled diagnostic strategies through clinical development, regulatory submission, and therapeutic approval.
Responsibilities
- Set and lead global CDx strategy across the pipeline and technologies, aligning with clinical strategy, regulatory requirements, and launch planning.
- Translate biomarker hypotheses into diagnostic target product profiles across platforms (NGS, PCR, IHC, immunoassays).
- Define assay development strategy from feasibility through validation, submission, and lifecycle planning.
- Provide executive oversight of external IVD sponsors, laboratories, and technology partners.
Skills
Education
Job description
Regeneron Pharmaceuticals, Inc. seeks a Senior Director to set strategy and drive execution across a portfolio of companion diagnostics (CDx) programs.
You will lead a team of diagnostic professionals and align diagnostic plans with clinical development, regulatory submissions, launch readiness, and patient access objectives. You will translate biomarker hypotheses into fit-for-purpose diagnostic plans, define assay strategies, and influence cross-functional partners including translational
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