Associate Director, CDx Strategy & Diagnostics

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Job summary

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

You will set global CDx strategy, collaborate with translational and clinical teams, and manage external IVD partners to ensure diagnostics align with therapeutic milestones and regulatory

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.
• Experience with global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA) and external partners management.
• Ability to translate complex scientific data for cross-functional and executive audiences.

Responsibilities

• Translate emerging biomarker data into diagnostic target product profiles (TPPs) and define assay intent across platforms (NGS, PCR, IHC, immunoassays).
• Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, LOD, reproducibility) and link assay performance to clinical endpoints.
• Set global CDx strategy and align diagnostic milestones with clinical and regulatory timelines.
• Oversee IVD development partners, manage co-development scope and quality expectations, and support regulatory submissions.

Skills

CDx strategy

Cross-functional leadership

Regulatory submissions

External partnerships

Education

PhD in molecular biology

Tools

Next Generation Sequencing

PCR

Immunohistochemistry

Immunoassays

Job description

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

You will set global CDx strategy, collaborate with translational and clinical teams, and manage external IVD partners to ensure diagnostics align with therapeutic milestones and regulatory