CDx Strategy Lead, Precision Medicine

Regeneron Pharmaceuticals, Inc.

Uxbridge

On-site

GBP 140,000 - 190,000

Full time

14 days+

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Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead CDx strategy, bridging translational science with diagnostic execution.

You will own CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch. This role interfaces biomarker science, clinical development, regulatory, and external IVD partners to align diagnostics with therapeutic milestones.

Qualifications

PhD or equivalent advanced degree in a relevant field.
8+ years in diagnostics or translational research with 4+ years leading CDx/IVD programs.
Proven track record translating biomarker science into validated assays.
Experience with global CDx regulatory pathways.
Ability to communicate complex data to cross-functional and executive audiences.

Responsibilities

Translate biomarker data into diagnostic target product profiles for cross-platform assays.
Design biomarker strategies for patient selection and enrichment.
Lead analytical and clinical validation planning and link to clinical endpoints.
Set global CDx strategy aligning milestones with regulatory timelines.
Oversee external IVD partners and co-development timelines.
Support regulatory submissions and labeling alignment.
Ensure ISO 13485/14971, CLSI, IVDR alignment and QMS compliance.
Lead cross-functional governance and program plans.