Senior Manager, Precision Medicine – Clinical Diagnostics

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $150.5k - $245.5k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 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

• Execute end-to-end companion diagnostics strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines • Lead cross-functional teams, integrate workstreams, clear obstacles, and provide status reporting to governance bodies and senior leadership • Manage IVD partners, negotiating scope, timelines, budgets, and quality • Oversee co-development and Joint Steering Committees • Define assay intent and contribute to target product profiles for CDx platforms including NGS, PCR, IHC, and immunoassays • Drive analytical and clinical validation • Embed CDx assays in clinical trials, covering screening/stratification, sampling, site readiness, and lab operations • Partner with IVD Regulatory on global submissions, supporting pre-subs, labeling, and responses • Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP frameworks • Maintain documentation and audit readiness • Collaborate across biomarker, clinical, regulatory, commercial, and IVD functions

🎯 Requirements

• PhD in molecular biology, pathology, biomedical engineering, or equivalent • 4+ years in diagnostics development • 2+ years leading CDx/IVD programs in pharma or diagnostics organizations • Proven delivery of CDx aligned to drug approvals, with successful validation and regulatory submissions • Expertise in NGS, PCR, IHC, and immunoassays • Expertise in validation standards and quality systems • Strong grasp of global regulatory pathways, including FDA CDRH, EU IVDR, and PMDA, for CDx labeling • Excellent communication, leadership, and stakeholder management skills • Ability to deliver clear updates to executive audiences

🏖️ 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