Senior Manager, Precision Medicine - Clinical Diagnostics
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics (CDx) strategy and execution across our therapeutic indications. In this role, you will translate scientific needs into fit-for-purpose assays for global decisions, owning programs from feasibility through validation, registration, launch, and post-market sustainment, while partnering with biomarker, clinical, regulatory, commercial, and IVD collaborators.
Job description
Discover your role
- Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines
- Lead cross-functional teams, integrate workstreams, clear obstacles, and provide transparent status reporting to governance bodies and senior leadership
- Manage IVD partners, negotiating scope, timelines, budgets, and quality, and overseeing co-development and Joint Steering Committees
- Define assay intent and contribute to target product profiles for CDx platforms (e.g., NGS, PCR, IHC, Immunoassays), driving analytical and clinical validation
- Embed CDx assays in trials with clinical teams, covering screening/stratification, sampling, site readiness, and lab operations
- Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs, labeling, and responses
- Ensure compliance with quality and regulatory frameworks (ISO 13485/14971, CLSI, IVDR, GCP), maintaining documentation and audit readiness
- Thrive in a fast-paced, multi-tasking environment, bringing strong communication skills to cross-functional collaboration.
This role requires
- PhD in molecular biology, pathology, biomedical engineering, or equivalent
- 4+ years in diagnostics development, including 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, along with validation standards and quality systems
- Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling
- Excellent communication, leadership, and stakeholder management skills, with the ability to deliver clear updates to executive audiences
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, along with validation standards and quality systems
- Strong grasp of global regulatory pathways (FDA CDRH, EU IVDR, PMDA) for CDx labeling
- Excellent communication, leadership, and stakeholder management skills, with the ability to deliver clear updates to executive audiences
Benefits
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension Or Retirement Benefits
- 401(k) Company Match
- Health And Wellness Programs
- Fitness Centers
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Paid Time Off
- Family Support Benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.