CDx Strategy Lead — Companion Diagnostics

Regeneron Pharmaceuticals; Armonk (NY); On-site; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution at Armonk and nearby sites.

You will own CDx programs from early biomarker feasibility through regulatory submission and launch, collaborating with translational science, clinical development, regulatory, and external IVD partners to deliver validated assays that inform drug development decisions.

Qualifications

• PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related field.
• 8+ years in diagnostics or translational research with 4+ years leading CDx/IVD programs.
• Experience translating biomarker science into validated assays for drug approvals.

Responsibilities

• Define global CDx strategy and align milestones with regulatory timelines.
• Lead validation planning (analytical/clinical) and link performance to safety and efficacy.
• Oversee IVD development partners and manage co-development timelines.
• Support regulatory submissions (FDA PMA, EU IVDR) with regulatory teams.
• Collaborate with translational, clinical, and external partners.

Skills

Biomarker strategy

CDx programs

Regulatory submissions

Cross-functional leadership

External partner management

Education

PhD or advanced degree

Job description

Regeneron Pharmaceuticals seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution at Armonk and nearby sites.

You will own CDx programs from early biomarker feasibility through regulatory submission and launch, collaborating with translational science, clinical development, regulatory, and external IVD partners to deliver validated assays that inform drug development decisions.