Remote Associate Director, Precision Medicine Diagnostics

Regeneron Pharmaceuticals; United States; Remote; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking an Associate Director to lead companion diagnostic strategy and development, bridging translational science with diagnostic execution. You will own CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch.

You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones.

Qualifications

• 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 data for cross-functional and executive audiences.
• Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

Responsibilities

• Translate biomarker data into diagnostic target product profiles and cross-platform assay intents.
• Partner with translational and clinical teams to design biomarker strategies for patient selection and enrichment.
• Lead analytical and clinical validation planning and link assay performance to safety and efficacy endpoints.
• Set global CDx strategy and align diagnostic milestones with regulatory timelines.
• Oversee IVD development partners, manage co-development scope and quality expectations.
• Support regulatory submissions (FDA PMA/supplement, EU IVDR, PMDA) and labeling alignment.
• Ensure compliance with ISO 13485, ISO 14971, CLSI, IVDR, and GCP guidelines.
• Lead cross-functional working groups and governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial/medical affairs.

Skills

CDx strategy

Regulatory awareness

Cross-functional leadership

IVD program management

Education

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

Job description

Regeneron Pharmaceuticals is seeking an Associate Director to lead companion diagnostic strategy and development, bridging translational science with diagnostic execution. You will own CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch.

You will work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones.