Remote Associate Director, Companion Diagnostics Strategy

Regeneron Pharmaceuticals, Inc (USA); United States; Remote; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution.

The role owns programs from feasibility through validation, regulatory submission, and launch, translating biological insights into validated assays that guide drug development decisions. You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure

Qualifications

• 8+ years in diagnostics or translational research
• 4+ years leading biomarker-driven CDx or IVD programs
• Track record translating biomarker science into validated assays
• Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA)
• Ability to translate complex scientific data for cross-functional/executive audiences
• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions

Responsibilities

• Translate biomarker and mechanism-of-action data into diagnostic target profiles across platforms
• Design biomarker strategies for patient selection, stratification and enrichment
• Lead analytical and clinical validation planning linking assay performance to clinical endpoints
• Set global CDx strategy aligning diagnostic milestones with clinical/regulatory timelines
• Select and oversee IVD development partners and manage co-development scope
• Support regulatory submissions (FDA PMA/supplement, EU IVDR, PMDA) with regulatory teams
• Ensure compliance with ISO 13485/14971/CLSI/IVDR and GCP alignment
• Lead cross-functional governance reporting and drive launch readiness preparations

Skills

Cross-functional collaboration

Regulatory knowledge

Executive communication

External partner management

Program leadership

Education

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

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution.

The role owns programs from feasibility through validation, regulatory submission, and launch, translating biological insights into validated assays that guide drug development decisions. You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure