Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals•Armonk, NY

3d•$114,800 - $187,400•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a 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.

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.

Responsibilities

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.