Senior CDx Strategy Lead – Precision Medicine

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

Job summary

Regeneron seeks an Associate Director to lead 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 translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions.

You’ll work at the interface of biomarker science, clinical development, regulatory, and external

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

Responsibilities

• Define CDx strategy and target product profiles across platforms.
• Lead analytical and clinical validation planning.
• Oversee IVD development partners and co-development scope.
• Support regulatory submissions (FDA PMA, EU IVDR, PMDA).
• Ensure ISO/CLSI/GxP compliance.

Skills

CDx strategy

Biomarker development

Cross-functional leadership

Regulatory knowledge

Education

PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field

Job description

Regeneron seeks an Associate Director to lead 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 translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions.

You’ll work at the interface of biomarker science, clinical development, regulatory, and external