Associate Director, Clinical Data Management – Program Lead

Regeneron Pharmaceuticals; Cambridge (MA); Hybrid; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an Associate Director, Clinical Data Management, Program Lead to steer CDM activities across assigned clinical programs. You will ensure quality, timelines and budgets while collaborating with senior leadership, study teams, and external partners.

The role requires a bachelor’s degree and 10+ years in CDM with 5+ years in people leadership, plus strong knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.

Qualifications

• Bachelor’s degree in Mathematics, Science, or a related field.
• 10+ years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry and 5+ years of people management experience.
• Solid understanding of 21 CFR Part 11, ICH-GCP guidelines, and CDISC standards for data collection.
• Proven record of leading studies and study teams, with the ability to motivate virtual teams in a matrix environment.
• Strong problem-solving, project management, and communication skills in a fast-paced setting.
• Certified Clinical Data Manager (CCDM) certification is preferred.

Responsibilities

• Lead the overall success of CDM deliverables across studies and programs.
• Communicate program status, risks, and issues proactively to collaborators and develop mitigation strategies.
• Provide CDM expertise during protocol design, study start-up, and study conduct, promoting consistent standards and best practices.
• Oversee program timelines, resources, and budgets, and serve as the escalation point for program and study issues.
• Track metrics and KPIs, and manage Quality Events, CAPAs, and process deviations.
• Represent CDM in review committees, CRO governance, and joint meetings with collaborators.
• Drive inspection readiness and coordinate CDM activities during regulatory inspections.
• Mentor and coach team members, and, where applicable, manage staff through recruitment, development, and performance management.

Skills

CCDM certification

Project management

Communication skills

Problem solving

Education

Bachelor’s degree in Mathematics, Science, or a related field

Job description

Regeneron Pharmaceuticals seeks an Associate Director, Clinical Data Management, Program Lead to steer CDM activities across assigned clinical programs. You will ensure quality, timelines and budgets while collaborating with senior leadership, study teams, and external partners.

The role requires a bachelor’s degree and 10+ years in CDM with 5+ years in people leadership, plus strong knowledge of 21 CFR Part 11, ICH-GCP, and CDISC.