Manager, Clinical Lab Project Management
Regeneron Pharmaceuticals
Summary
The Manager, Precision Medicine Clinical Laboratory Operations will be responsible for Clinical Laboratory Project & Program management for various therapeutic areas working closely with Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary role will be to keep laboratory deliverables across the portfolio on track, ensuring that study start timelines are met, provide risk management. This will be done in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues and central and specialty testing laboratories to support early and late-stage programs within our pipeline.
Job description
Discover Your Role
- Perform clinical laboratory portfolio management for complex Regeneron clinical trials and review clinical laboratory operations timelines and risks. Manage and communicate those risks to ensure study starts and data delivery are aligned with expectations
- Active knowledge on central and specialty laboratory processes; leverage this experience to be a trusted collaborator and ensure clinical laboratory deliverables
- Track biomarker strategy delivery schedules for clinical development programs/studies on track, identifying and tracking risks and decisions, creating mitigation plans
- Oversee clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines
- Liaise with internal and cross functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads and others within Global Development to manage and implement program level clinical laboratory management
- Demonstrate understanding of complex non-oncology clinical laboratory trial requirements on the program and implement operational decisions and harmony.
- Communicate with clinical study teams on laboratory program direction. Demonstrate knowledge for the studies related to the program.
This Role Requires
- Bachelors degree required, Masters degree preferred.
- Minimum of 8 years experience preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.
- Minimum of 5 years' experience with Clinical Trials, focus on clinical sample collection. Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested.
- We need a strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required. We are seeking clinical study knowledge, demonstrated by knowledge in science and technology.
Requirements
- Bachelors degree required, Masters degree preferred.
- Minimum of 8 years experience preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.
- Minimum of 5 years' experience with Clinical Trials, focus on clinical sample collection.
- Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested.
- Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required.
- Clinical study knowledge, demonstrated by knowledge in science and technology.
Benefits
- Annual bonuses
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical insurance
- Dental insurance
- Vision insurance
- Life and 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.