Associate Director Precision Medicine - Clinical Diagnostics

Regeneron Pharmaceuticals

2d • $176,100 - $287,300 • Remote

About The Position

Regeneron is seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. The role owns companion diagnostic 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. The Associate Director works across biomarker science, clinical development, regulatory, and external in vitro diagnostic (IVD) partners to ensure diagnostics align with therapeutic milestones.

Requirements

• PhD or advanced degree in molecular biology, pathology, biomedical engineering, or a related translational or biomedical science field.
• At least 8 years in diagnostics or translational research.
• At least 4 years leading biomarker-driven CDx or IVD programs that bridge bench discovery and clinical application.
• Track record translating biomarker science into validated assays supporting drug approvals.
• Working knowledge of global CDx regulatory pathways, including FDA CDRH, EU IVDR, and 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, defining assay intent across platforms including next-generation sequencing, polymerase chain reaction, immunohistochemistry, and 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, covering accuracy, precision, sensitivity and specificity, limit of detection, and reproducibility, and link assay performance to clinical safety and efficacy endpoints.
• Set global CDx strategy for assigned programs and align diagnostic milestones with clinical and regulatory timelines.
• Select and oversee IVD development partners, managing co-development scope, timelines, and quality expectations.
• Support global regulatory strategy and submissions, including FDA PMA or supplement, EU IVDR, and PMDA, in collaboration with IVD Regulatory, including labeling alignment.
• Ensure compliance with relevant standards, including ISO 13485, ISO 14971, CLSI, IVDR, and GCP alignment.
• Lead cross-functional working groups, translate scientific rationale into program plans, and provide clear governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

Benefits

• Annual bonuses or other incentive plans may be available, depending on country and role.
• Equity awards may be available, depending on country and role.
• Pension or retirement benefits may be available, depending on country and role.
• 401(k) company match may be available, depending on country and role.
• Health and wellness programs may be available, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability, may be available, depending on country and role.
• Paid time off may be available, depending on country and role.
• Family support benefits may be available, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree