Senior CDx Strategy Lead — Precision Medicine (Remote)

Regeneron Pharmaceuticals Inc.; United States; Remote; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution across global programs.

You'll own CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch, partnering with biomarker science, clinical development, regulatory, and external IVD partners. Location: Remote, USA.

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 and mechanism-of-action data into diagnostic target product profiles, defining assay intent across platforms (Next Generation Sequencing, PCR, IHC, immunoassays).
• Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
• Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, LOD, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
• Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
• Select and oversee IVD development partners; manage co-development scope, timelines, and quality expectations.
• Support global regulatory strategy and submissions (FDA PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
• Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
• Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

Skills

Biomarker strategy

CDx development

Regulatory understanding

Cross-functional leadership

Education

PhD in molecular biology or related

Job description

Regeneron Pharmaceuticals Inc. is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution across global programs.

You'll own CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch, partnering with biomarker science, clinical development, regulatory, and external IVD partners. Location: Remote, USA.