Senior Director, Clinical Diagnostics – Precision Medicine

🔥 2 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $242k - $403.3k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Set and lead global companion diagnostics strategy across the entire therapeutic pipeline and all technologies • Integrate diagnostic plans with clinical strategy, development objectives and timelines, regulatory requirements, launch planning, and patient identification needs • Translate biomarker biology, mechanism-of-action hypotheses, and clinical utility considerations into diagnostic target product profiles • Define assay selection and development strategy from feasibility through analytical and clinical validation, regulatory submission, and post-approval lifecycle planning • Lead diagnostic strategies supporting patient selection, stratification, monitoring, and evidence generation • Oversee external IVD sponsors, laboratory and technology partner relationships, including selection, contracting, governance, budgets, and issue escalation • Ensure operational readiness of CDx testing in clinical trials, including study startup, laboratory workflows, sample management, data transfer, and quality oversight • Shape global CDx regulatory strategy with Regulatory Affairs, including FDA, EU IVDR, PMDA, and other regional requirements • Serve as senior CDx subject matter expert and strategic advisor to program teams and leadership • Influence decisions across translational medicine, clinical development, regulatory, biostatistics, clinical operations, commercial, medical affairs, market access, quality, and legal • Lead and develop a team of diagnostic professionals

🎯 Requirements

• Advanced degree (PhD, MD, MD/PhD, or equivalent) in molecular biology, pathology, translational medicine, oncology, biomedical engineering, diagnostics, or a related scientific discipline • 12 or more years of experience in companion diagnostics, IVD development, biomarker strategy, or translational medicine within pharma, biotech, or diagnostics • Progressive leadership responsibility • Demonstrated success leading CDx or biomarker-enabled diagnostic strategies through clinical development, regulatory submission, and therapeutic approval • Deep expertise in assay development, analytical and clinical validation, and clinical utility • Strong working knowledge of global CDx regulatory pathways, including FDA CDRH (PMA and supplemental submissions), EU IVDR, PMDA, performance studies, labeling, and post-approval obligations • Experience managing external diagnostic partners, IVD sponsors, central laboratories, CROs, and technology vendors within complex, timeline-sensitive programs • Proven people leadership, including mentoring talent, building capability, and setting priorities in a collaborative, accountable team environment

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required