Associate Director – Precision Medicine, Clinical Diagnostics

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $176.1k - $287.3k / year

⏰ Full Time

🟠 Senior

👔 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

• Lead companion diagnostic strategy and development from early biomarker feasibility through clinical validation, regulatory submission, and launch • Translate biomarker and mechanism-of-action data into diagnostic target product profiles and define assay intent across NGS, PCR, immunohistochemistry, and immunoassay platforms • Partner with translational and clinical teams on biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics • Lead analytical and clinical validation planning, including accuracy, precision, sensitivity/specificity, limit of detection, and reproducibility • Set global CDx strategy and align diagnostic milestones with clinical and regulatory timelines • Select and oversee IVD development partners and manage co-development scope, timelines, and quality expectations • Support global regulatory strategy and submissions, including FDA PMA/supplement, EU IVDR, and PMDA, with IVD Regulatory • Ensure compliance with ISO 13485, ISO 14971, CLSI, IVDR, and GCP-alignment standards • Lead cross-functional working groups and translate scientific rationale into program plans and governance reporting • Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs

🎯 Requirements

• PhD or advanced degree in molecular biology, pathology, biomedical engineering, or a related translational/biomedical science field • 8+ years in diagnostics or translational research • 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, including FDA CDRH, EU IVDR, and PMDA • Ability to translate complex scientific and clinical data for cross-functional and executive audiences • Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions

🏖️ 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 for applicants with known disabilities or chronic illnesses