Associate Director, Precision Medicine (Clinical Diagnostics)

Regeneron · Armonk +2 more

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Clinical OperationsFull-time$176k–$287kCompany career page

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Role summary

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.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-08-18). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

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

What you'll be doing

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

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Date posted47 days ago

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