Director, Clinical Data Management — Therapeutic Area Lead

BioSpace; Cambridge (MA); Hybrid; USD 183,000 - 305,000; Full time

Job summary

Regeneron is seeking a Director of Clinical Data Management in Cambridge, MA, to lead the Data Management organization and serve as Therapeutic Area Head in a hybrid work model. You will set the data management vision, ensure inspection-ready data, and coach a team of managers and data managers while collaborating with cross-functional partners and CROs.

The role requires a Bachelor’s degree in Mathematics/Science with CCDM certification, 12+ years in the field, and 5+ years of people

Qualifications

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

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

Vendor management

Data management

Cross-functional collaboration

Stakeholder management

Project management

Communication

Education

Bachelor's degree

CCDM certification

Job description

Regeneron is seeking a Director of Clinical Data Management in Cambridge, MA, to lead the Data Management organization and serve as Therapeutic Area Head in a hybrid work model. You will set the data management vision, ensure inspection-ready data, and coach a team of managers and data managers while collaborating with cross-functional partners and CROs.

The role requires a Bachelor’s degree in Mathematics/Science with CCDM certification, 12+ years in the field, and 5+ years of people