Senior Director, Clinical Diagnostics and Precision Medicine

Regeneron seeks a senior leader to establish and execute companion diagnostics strategy across its therapeutic pipeline. This role involves integrating diagnostic approaches with clinical development, regulatory requirements, and commercial objectives while leading a team of diagnostic professionals and managing external partners.

Responsibilities

• Establish and lead global companion diagnostics strategy integrated with clinical development and regulatory timelines
• Translate biomarker biology into diagnostic target product profiles across NGS, PCR, immunohistochemistry, and emerging platforms
• Define assay selection and development strategy from feasibility through validation, submission, and post-approval lifecycle
• Lead team developing diagnostic strategies for patient selection, stratification, monitoring, and evidence generation
• Provide executive oversight of external IVD partners, laboratories, and technology vendors including selection and governance

Requirements

• Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, or related field
• 12+ years in companion diagnostics, IVD development, biomarker strategy, or translational medicine in pharma/biotech
• Demonstrated success leading CDx strategies through clinical development, regulatory approval, and market launch
• Deep expertise in assay development, analytical validation, and clinical utility assessment
• Strong knowledge of global CDx regulatory pathways including FDA CDRH, EU IVDR, and PMDA requirements
• Experience managing external diagnostic partners, IVD sponsors, and central laboratories in complex programs
• Proven people leadership with mentoring capability and collaborative team management