Senior Manager, Clinical Lab Project Management
Regeneron Pharmaceuticals
Summary
The Senior 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 Regeneron clinical trials and review clinical laboratory operations timelines and risks and be able to manage and communicate risks and ensure study starts and data delivery are aligned with expectations
- Be a subject matter expert on central and specialty laboratory processes and leverage this knowledge to be a trusted collaborator and ensure clinical laboratory deliverables
- Keep biomarker strategy delivery schedules for clinical development programs and studies on track, identifying and tracking risks and decisions, creating mitigation plans
- Manage clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines
- Manage strong relationships and trust 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 relevant knowledge and understanding of clinical laboratory trial requirements on the program and implement operational decisions. Ensure the laboratory portion of the studies are harmonized for assigned program from onset to final delivery
- Be viewed as an operational subject matter expert to effectively communicate with clinical study teams on laboratory program direction. Demonstrate authority for the studies related to the program.
- Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment, design and develop processes to address identified gaps
This Role Requires
- Bachelors degree required, Masters degree preferred.
- Minimum of 10 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 10 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
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- 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.