Associate Director, Precision Medicine (Clinical Diagnostics)
$176.1k - $287.3kRegeneron Pharmaceuticals, Inc.
Regeneron seeks an Associate Director to lead companion diagnostic strategy and development from biomarker feasibility through regulatory submission and launch. The role bridges translational science with clinical diagnostics, managing CDx programs across multiple platforms while coordinating with biomarker, clinical, regulatory, and external IVD partners. Requires a PhD in molecular biology, pathology, or related field, plus 8+ years in diagnostics with 4+ years leading biomarker-driven programs.
Responsibilities
- Develop diagnostic target product profiles translating biomarker data across NGS, PCR, immunohistochemistry, immunoassay platforms
- Design biomarker strategies for patient selection, stratification, and enrichment with translational and clinical teams
- Lead analytical and clinical validation planning linking assay performance to safety and efficacy endpoints
- Set global CDx strategy aligning diagnostic milestones with clinical and regulatory timelines
- Select and oversee IVD development partners; manage scope, timelines, and quality expectations
Requirements
- PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related field
- 8+ years diagnostics or translational research experience
- 4+ years leading biomarker-driven CDx or IVD programs
- Demonstrated success translating biomarker science into validated assays for drug approvals
- Working knowledge of FDA CDRH, EU IVDR, and PMDA regulatory pathways
- Experience managing external partners and multi-workstream programs under QMS/GxP conditions
- Ability to communicate complex scientific data to cross-functional and executive audiences
Compensation: $176,100 - $287,300 annually
Vacancy posted 6 days ago
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