Senior CDx Strategy Lead - Precision Medicine (Remote)

BioSpace

United States

Remote

USD 176,000 - 287,000

Full time

2 days ago

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Job summary

Regeneron is seeking an Associate Director to lead companion diagnostic strategy and development, bridging translational science with diagnostic execution for drug development decisions. You will own CDx programs from feasibility to clinical validation and launch, coordinating with biomarker science, clinical development, regulatory, and external IVD partners.

The role requires a PhD or advanced degree in molecular biology or related field and 8+ years in diagnostics, with 4+ years leading

Qualifications

PhD or advanced degree required.
8+ years in diagnostics or translational research.
Experience leading biomarker-driven CDx/IVD programs.
Regulatory familiarity with FDA, EU IVDR and PMDA.

Responsibilities

Translate biomarker and mechanism data into diagnostic target product profiles across platforms.
Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity).
Set global CDx strategy aligned with clinical and regulatory timelines.
Select and oversee IVD development partners; manage co-development scope and quality expectations.
Support regulatory submissions and labeling alignment with Regulatory teams.