Associate Director, Precision Medicine Clinical Laboratory Operations

The Associate Director, 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 provide strategic oversight of laboratory deliverables across the portfolio, ensuring that study start timelines are met, provide risk management. Collaborates with stakeholders for all aspects of clinical laboratory deliverables (from study conduct, sample management testing to launch). 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. 

As an Associate Director, a typical day may include the following: 

• Perform strategic and 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 

• Works closely with collaborators to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies, identifying and tracking risks and decisions, creating mitigation plans 

• Required to inform and shape clinical laboratory operations goals, including progress, schedules of testing/data generation across the portfolio with clear objectives and deadlines 

• Develop 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 strategic 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. Established as a leader for the program and can dive into the details when required, with attention to detail 

• 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 may be for you if: 

• You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment 

• You demonstrate strong leadership skills and possess high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success 

To be considered for this role, you must have Bachelors, Minimum of 10 years pharmaceutical experience in matrix interaction 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