Director, Clinical Data Management - Strategy & QA Leader

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

Job summary

Regeneron Pharmaceuticals in Cambridge, MA, leads the data management function as Therapeutic Area Head, setting vision and strategy for data capture, quality, and analysis. The role involves coaching managers, ensuring inspection-ready data, and partnering with CROs in a hybrid work model.

With 12+ years in clinical data management and CCDM certification, you will shape organizational goals, manage resources, and drive high standards across studies in a fast-paced environment.

Qualifications

• Bachelor’s degree in Mathematics, Science, or related field.
• CCDM certification required.
• 12+ years of clinical data management experience.

Responsibilities

• Lead, coach, and mentor data management staff across teams.
• Oversee portfolio-level execution, milestones, risks, and issues.
• Partner with senior leadership to shape goals and resources.
• Hold CROs and vendors accountable for quality and compliance.
• Drive inspection readiness and quality gap resolution.
• Build cross-functional relationships and manage conflicts.
• Sponsor and lead initiatives in leadership forums.

Skills

Regulatory knowledge

GCP/CDISC

Problem solving

Project management

Communication

Leadership

Education

Bachelor’s degree in Mathematics/Science

CCDM certification

Job description

Regeneron Pharmaceuticals in Cambridge, MA, leads the data management function as Therapeutic Area Head, setting vision and strategy for data capture, quality, and analysis. The role involves coaching managers, ensuring inspection-ready data, and partnering with CROs in a hybrid work model.

With 12+ years in clinical data management and CCDM certification, you will shape organizational goals, manage resources, and drive high standards across studies in a fast-paced environment.