Lead, Precision Medicine CDx Strategy & Development

Regeneron Pharmaceuticals; Uxbridge (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch.

You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones and align with program goals.

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.
• Track record translating biomarker science into validated assays supporting drug approvals.

Responsibilities

• Translate emerging biomarker data into diagnostic target profiles and assay intent across platforms.
• Design biomarker strategies for patient selection, stratification, and enrichment including samples logistics.
• Lead analytical and clinical validation planning and link assay performance to clinical endpoints.
• Set global CDx strategy and align diagnostic milestones with clinical and regulatory timelines.
• Manage external IVD development partners and co-development scope, timelines, and quality expectations.

Skills

Biomarker strategy

Cross-functional leadership

Regulatory submissions support

External partner management

Education

PhD or advanced degree in molecular biology/biomedical field

Job description

Regeneron Pharmaceuticals seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch.

You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones and align with program goals.