Therapeutic Area Lead - Clinical Data Management

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

Benefits offered by this job

Hybrid work model

Job summary

Regeneron Pharmaceuticals, Inc. in Cambridge, MA is hiring a Director of Clinical Data Management to lead the Data Management organization and set vision for therapeutic data management. The role is hybrid with onsite expectations across Cambridge, MA; Warren, NJ; and Armonk, NY.

You will coach managers and data managers, oversee portfolio milestones, shape department goals, and ensure high-quality, inspection-ready data while partnering with CROs and outsourcing vendors.

Qualifications

• Bachelor's degree in Mathematics, Science, or related field; CCDM certification.
• 12+ years of clinical data management experience in biotech/pharma or health-related industry.
• 5+ years of people management experience.
• Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Proven record of leading studies and virtual teams in a matrix environment.
• Strong problem-solving, project management, and communication skills with a strategic approach.

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.
• Build strong relationships across teams by negotiating effectively, managing conflict, and collaborating.
• Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums.

Skills

Leadership

People management

Communication

Strategic thinking

Problem solving

Education

Bachelor's degree in Math/Science

CCDM certification

Job description

Regeneron Pharmaceuticals, Inc. in Cambridge, MA is hiring a Director of Clinical Data Management to lead the Data Management organization and set vision for therapeutic data management. The role is hybrid with onsite expectations across Cambridge, MA; Warren, NJ; and Armonk, NY.

You will coach managers and data managers, oversee portfolio milestones, shape department goals, and ensure high-quality, inspection-ready data while partnering with CROs and outsourcing vendors.