Senior CDx Strategy Lead - Precision Medicine

Regeneron Pharmaceuticals, Inc

Armonk (NY)

Hybrid

USD 176,000 - 287,000

Full time

6 days ago

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Job summary

Regeneron Pharmaceuticals, Inc is seeking an Associate Director to lead CDx strategy and development, bridging translational science with diagnostic execution. The role owns CDx programs from feasibility through clinical validation, regulatory submission, and launch, translating biomarker insights into validated assays that guide drug development decisions.

The position involves coordinating with biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics

Qualifications

8+ years in diagnostics or translational research.
4+ years leading biomarker-driven CDx or IVD programs bridging bench to clinic.
Track record translating biomarker science into validated assays.

Responsibilities

Translate biomarker and MOA data into diagnostic target product profiles across platforms (NGS, PCR, IHC).
Partner with translational and clinical teams to design biomarker strategies for patient selection and enrichment.
Lead analytical and clinical validation planning and link assay performance to safety/efficacy endpoints.
Set global CDx strategy aligning diagnostic milestones with timelines.
Oversee IVD development partners and manage co-development scope and quality.
Support global regulatory strategy and submissions with regulatory teams.
Ensure compliance with ISO/CLSI/IVDR/GCP-related standards.
Lead cross-functional teams and governance reporting.
Support design transfer, manufacturing readiness, and launch preparation.