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 timelines are met and risks are managed.

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, identifying risks and decisions, creating mitigation plans; manage complex biomarker deliverables with internal and external colleagues.
• Inform and shape clinical laboratory operations goals, including progress and data generation schedules across the portfolio with clear objectives and deadlines.
• Develop strong relationships with internal and cross-functional partners, senior leadership, and Global Development 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.
• Act as an operational subject matter expert, communicate with study teams on laboratory program direction, provide frequent executive summaries, and lead the program with attention to detail.
• Bridge laboratory operations with research teams and tech centers, manage lab delivery timelines in clinical trials and human sample projects for seamless execution.
• Provide subject matter expertise on human sample management, including acquiring samples and pursuing new project ideas to support research initiatives.
• Create and communicate enhancements to Clinical Laboratory Project Management and design processes to address gaps.
• Lead decision-making forums for clinical lab strategy within the portfolio and adjust processes as needed, with forward-thinking, big-picture thinking.
• Ensure laboratory components of studies are harmonized from onset to final delivery; demonstrate leadership, problem-solving, and cross-functional collaboration.
• Manage staff recruitment, development, coaching, mentoring, and performance management.

Qualifications

• 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.
• Minimum of 5 years’ experience with Clinical Trials, focusing on clinical sample collection.
• Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
• Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.
• Clinical study knowledge demonstrated by science and technology understanding.
• Demonstrated experience in stakeholder management and leading internal and external meetings with solutioning skills.

Skills

• Clinical laboratory operations
• Biomarker strategy and delivery planning
• Vendor and project management
• ICH/GCP knowledge
• Strategic thinking and risk management
• Cross-functional collaboration and leadership

Education

• Bachelor’s Degree (required).

Additional Requirements

• On-site work may be required; discuss location with recruiter.