Associate Director, Precision Medicine & CDx Strategy

Meeveem Limited

Uxbridge

Hybrid

GBP 90,000 - 150,000

Full time

14 days+

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Job summary

Regeneron in the United Kingdom seeks an Associate Director to lead CDx strategy and development, bridging translational science with diagnostic execution. This role steers CDx programs from feasibility through clinical validation, regulatory submission, and launch, translating biological insights into validated assays supporting drug development decisions.

The role interfaces with biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with

Qualifications

PhD or advanced degree in a translational/biomedical science field.
8+ years in diagnostics or translational research; 4+ years leading CDx or IVD programs.
Experience translating biomarker science into validated assays for drug approvals.
Knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
Ability to present complex data to cross-functional and executive audiences.

Responsibilities

Translate biomarker data into diagnostic target product profiles across platforms (NGS, PCR, IHC, immunoassays).
Design biomarker strategies for patient selection, stratification and enrichment, including sample strategy and logistics.
Lead analytical and clinical validation planning and link assay performance to safety and efficacy endpoints.
Set global CDx strategy aligning diagnostic milestones with timelines.
Oversee external IVD development partners and co-development scope.