Associate Director, Precision Medicine Operations

Role Summary

Associate Director, Precision Medicine Operations at Regeneron. Responsible for Clinical Laboratory Project & Program management across therapeutic areas, providing strategic oversight of biomarker operational delivery and clinical laboratory deliverables, ensuring study start timelines, risk management, and collaboration with cross-functional teams to support early and late-stage programs.

Responsibilities

• Perform strategic and clinical laboratory portfolio management for Regeneron clinical trials based on clinical trial protocol requirements and schedule of events/assessments.
• Lead program teams through operational lab delivery; review timelines and risks, manage and communicate risks, and ensure study starts and data delivery align with expectations.
• Be a subject matter expert on central and specialty laboratory processes, lab project management, vendor management, ICH/GCP, and leverage this knowledge to ensure clinical laboratory deliverables.
• Collaborate with stakeholders to plan, monitor, and update biomarker strategy delivery schedules for clinical development programs and studies; identify and track risks and decisions; create mitigation plans; manage delivery of complex biomarker deliverables with internal and external colleagues.
• Inform and shape clinical laboratory operations goals, including progress and schedules of testing/data generation across the portfolio with clear objectives and deadlines.
• Develop strong relationships with internal and cross-functional partners to manage and implement program-level clinical laboratory management.
• Oversee operational aspects of clinical trial laboratory implementation and communicate effectively externally and internally; identify solutions for barriers to success in the clinical laboratory space.
• Serve as an operational subject matter expert to communicate with clinical study teams on laboratory program direction; provide frequent executive summaries and demonstrate leadership for the program.
• Bridge laboratory clinical trial operations with research teams and tech centers to manage lab delivery timelines and ensure seamless execution and adherence to deadlines.
• Provide subject matter expertise on human sample management projects, including acquiring samples from outside sources and supporting new project ideas for innovative research.
• Create and communicate enhancements to Clinical Laboratory Project Management; design and develop processes to address identified gaps.
• Lead and facilitate decision-making forums for clinical lab strategy; identify and adjust processes as required with forward-thinking, big-picture skills.
• Ensure laboratory components of studies are harmonized from onset to final delivery; exercise leadership, problem-solving, and cross-functional collaboration.
• Lead line management responsibilities including staff recruitment, development, coaching, mentoring, and performance management.

Qualifications

• Required: Bachelor's Degree with a minimum of 8 years of pharmaceutical experience in matrix environments, preferably in pharma/biotech or academic/government cross-disciplinary teams.
• Required: Minimum of 5 years‚Äô experience with Clinical Trials, focusing on clinical sample collection.
• Required: Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
• Required: Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.
• Required: Clinical study knowledge demonstrated by knowledge in science and technology.
• Required: Demonstrated experience in stakeholder management, leading internal and external meetings, and solutioning skills.

Skills

• Clinical laboratory operations management
• Biomarker strategy delivery and biomarker project management
• Vendor management and central/specialty laboratory processes
• ICH/GCP knowledge and regulatory compliance
• Cross-functional alliance building and executive communication
• Strategic planning, risk management, and problem solving
• Leadership and people management

Education

• Bachelors Degree (required)