Director, Clinical Data Management — Hybrid Lead

Regeneron Pharmaceuticals, Inc (USA); Cambridge (MA); Hybrid; USD 183,000 - 305,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Director of Clinical Data Management to lead and shape data management strategy, ensure high-quality, inspection-ready data, and mentor a team of managers and data managers. The role sits within a hybrid work model and collaborates with cross-functional partners and vendors.

Responsibilities include guiding portfolio execution, setting goals, and ensuring quality across studies, while maintaining strong relationships with leadership and sponsors.

Qualifications

• 12+ years of clinical data management experience in biotechnology, pharmaceutical, or health-related industries.
• 5+ years of people management experience.
• Bachelor's degree in Mathematics, Science, or related field and CCDM certification.
• Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Proven record of leading studies and study teams, and motivating virtual teams in a matrix environment.

Responsibilities

• Lead, coach, and mentor managers and data managers, providing performance feedback and growth opportunities.
• Oversee portfolio-level execution, tracking milestones and deliverables, and resolving risks and critical issues.
• Partner with senior leadership to shape department goals, organizational structure, and resource allocation.
• Hold CROs and vendors accountable for quality and compliance, and help build long-term outsourcing partnerships.
• Drive inspection and audit readiness, overseeing the team through inspections and quality gap resolution.
• Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums.

Skills

Leadership

Project management

Communication

Strategic thinking

Mentoring

Education

Bachelor's degree in Mathematics/Science or related field

Certified Clinical Data Manager (CCDM)

Tools

21 CFR Part 11

ICH-GCP

CDISC standards

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Director of Clinical Data Management to lead and shape data management strategy, ensure high-quality, inspection-ready data, and mentor a team of managers and data managers. The role sits within a hybrid work model and collaborates with cross-functional partners and vendors.

Responsibilities include guiding portfolio execution, setting goals, and ensuring quality across studies, while maintaining strong relationships with leadership and sponsors.