Associate Director, CDx Strategy & Launch (Remote)

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

Job summary

Regeneron Pharmaceuticals, Inc 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 regulatory submission and launch, translating biological insights into validated, fit-for-purpose assays that support drug development decisions.

You will partner with translational, clinical, regulatory, and external IVD partners to ensure

Qualifications

• PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
• 8+ years in diagnostics or translational research.
• 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 emerging biomarker and mechanism-of-action data into diagnostic target product profiles across platforms (NGS, PCR, IHC, immunoassays).
• Partner with translational and clinical teams to design biomarker strategies for patient selection and enrichment.
• Lead analytical and clinical validation planning for accuracy, precision, sensitivity/specificity, LOD, and reproducibility.
• Set global CDx strategy for assigned programs, aligning milestones with regulatory timelines.
• Select and oversee IVD development partners; manage co-development scope and timelines.
• Support global regulatory strategy and submissions (FDA PMA, EU IVDR, PMDA).
• Ensure compliance with ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment.
• Lead cross-functional working groups and governance reporting.
• Support design transfer, manufacturing readiness, and launch preparation with commercial/medical affairs.

Education

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

8+ years in diagnostics or translational research

Experience leading biomarker-driven CDx or IVD programs

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

Ability to translate complex data for cross-functional audiences

Experience managing external partners and multi-workstream programs

Job description

Regeneron Pharmaceuticals, Inc 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 regulatory submission and launch, translating biological insights into validated, fit-for-purpose assays that support drug development decisions.

You will partner with translational, clinical, regulatory, and external IVD partners to ensure