Associate Director, Precision Medicine (Clinical Diagnostics)

Regeneron · Dublin

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Clinical OperationsFull-timeCompany career page

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What they're looking for

PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related field
8+ years in diagnostics or translational research
4+ years leading biomarker-driven companion diagnostic or IVD programs
Track record 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 quality/GxP conditions
Ability to communicate complex scientific data to cross-functional and executive audiences

What you'll be doing

Develop companion diagnostic target product profiles and assay strategies across multiple platforms
Design biomarker strategies for patient selection, stratification, enrichment, and specimen logistics
Lead analytical and clinical validation planning linked to clinical safety and efficacy endpoints
Establish global CDx strategy aligned with clinical and regulatory timelines for assigned programs
Select and manage In Vitro Diagnostic development partners; oversee scope, timelines, and quality

Compensation€101,500.00 - €165,200.00 annually

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Date posted17 days ago

Last source check1 day ago

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