Senior Manager, Precision Medicine - Clinical Diagnostics
About The Position
Regeneron is seeking a Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics (CDx) strategy and execution across therapeutic indications. The role translates scientific needs into fit-for-purpose assays for global decisions and owns programs from feasibility through validation, registration, launch, and post-market sustainment. It partners with biomarker, clinical, regulatory, commercial, and in vitro diagnostics (IVD) collaborators. The position is remote in the USA and offers the opportunity to contribute to a fast-growing, science-driven organization developing medicines for people with serious diseases.
Requirements
- PhD in molecular biology, pathology, biomedical engineering, or equivalent.
- At least 4 years of experience in diagnostics development, including at least 2 years leading CDx/IVD programs in pharmaceutical or diagnostics organizations.
- Demonstrated delivery of CDx aligned to drug approvals, including successful validation and regulatory submissions.
- Expertise in NGS, PCR, IHC, immunoassays, validation standards, and quality systems.
- Strong understanding of global regulatory pathways for CDx labeling, including FDA CDRH, EU IVDR, and PMDA.
- Excellent communication, leadership, and stakeholder management skills, including the ability to provide clear updates to executive audiences.
Responsibilities
- Execute end-to-end CDx strategy, aligning diagnostic milestones with therapeutic clinical development and regulatory timelines.
- Lead cross-functional teams, integrate workstreams, remove obstacles, and provide transparent status reporting to governance bodies and senior leadership.
- Manage IVD partners by negotiating scope, timelines, budgets, and quality, and 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, while driving analytical and clinical validation.
- Embed CDx assays in trials with clinical teams, including screening and stratification, sampling, site readiness, and laboratory operations.
- Partner with IVD Regulatory on global submissions to FDA, EU IVDR, and PMDA, supporting pre-submissions, labeling, and responses.
- Ensure compliance with quality and regulatory frameworks, including ISO 13485/14971, CLSI, IVDR, and GCP, and maintain documentation and audit readiness.
- Communicate and collaborate effectively in a fast-paced, multitasking environment.
Benefits
- Competitive and comprehensive total rewards package, which may include 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, paid time off, and family support benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
