CDx Strategy Lead – Precision Medicine Diagnostics

Regeneron; Armonk (NY); Hybrid; USD 150,000 - 225,000; Full time

Job summary

Regeneron seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. The role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch, translating biological insights into validated assays for drug development decisions.

You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure

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.
• Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).

Responsibilities

• Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (NGS, qPCR, IHC, immunoassays).
• Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment.
• Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, LOD, reproducibility).
• Set global CDx strategy for assigned programs and align with 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).
• Ensure compliance with standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP).
• Lead cross-functional working groups and governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

Skills

CDx strategy

Biomarker development

Clinical translational science

Regulatory submissions

Cross-functional leadership

Partnership management

Education

PhD in molecular biology / biomedical sciences

Job description

Regeneron seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. The role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch, translating biological insights into validated assays for drug development decisions.

You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure