CDx Strategy Lead – Precision Medicine (Hybrid, Dublin)

Regeneron Pharmaceuticals

Dublin

Hybrid

EUR 102,000 - 165,000

Full time

14 days+

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Job summary

Regeneron Pharmaceuticals in Dublin, Ireland seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. The role spans from early biomarker feasibility to regulatory submission and launch, translating biological insights into validated assays for drug development decisions.

The candidate will coordinate with biomarker science, clinical development, regulatory, and external IVD partners to meet milestones,

Qualifications

PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
Experience translating biomarker science into validated assays to support drug approvals and familiarity with global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).

Responsibilities

Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles and define assay intent across platforms (NGS, PCR, IHC, immunoassays).
Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, LOD, reproducibility) linking assay performance to safety and efficacy endpoints.
Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
Select and oversee IVD development partners; manage co-development scope, timelines, and quality expectations.