Associate Director, CDx Strategy & Diagnostics

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

Job summary

Regeneron is seeking an Associate Director to lead companion diagnostic (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.

Qualifications

• PhD or advanced degree in molecular biology or related translational/biomedical 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).
• Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Responsibilities

• Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs).
• Design biomarker strategies for patient selection, stratification, and enrichment.
• Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity).
• Set global CDx strategy aligning diagnostic milestones with clinical and regulatory timelines.
• Oversee IVD development partners; manage co-development scope and timelines.
• Support regulatory submissions (FDA PMA/supplement, EU IVDR, PMDA).
• Lead cross-functional teams and governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation.

Skills

CDx strategy

Biomarker development

Regulatory submissions

Cross-functional leadership

IVD partnering

Translational science

Education

PhD in molecular biology or related field

Tools

NGS

PCR

IHC

Job description

Regeneron is seeking an Associate Director to lead companion diagnostic (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.