Strategic CDM Program Lead — Associate Director (Hybrid)

Regulatory Jobs; New Jersey; Hybrid; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking an Associate Director, Clinical Data Management, Program Lead to drive strategic CDM activities across clinical programs. You will lead timelines, budgets, and quality while collaborating with senior leadership, study teams, and external partners.

Location options include Warren, NJ, Armonk, NY or Tarrytown, NY with mostly onsite work and hybrid flexibility; you will mentor teams, manage staff, and ensure inspection readiness during regulatory reviews.

Qualifications

• Bachelor's degree in Mathematics, Science, or a related field.
• 10+ years of clinical data management experience in biotech/pharma/healthcare.
• 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 in a matrix environment.
• 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 manage staff through recruitment, development, and performance management.

Skills

Leadership

Project management

Communication

CDM expertise

Matrix leadership

Education

Bachelor's degree

Tools

CDISC standards

ICH-GCP

21 CFR Part 11

Job description

Regeneron Pharmaceuticals is seeking an Associate Director, Clinical Data Management, Program Lead to drive strategic CDM activities across clinical programs. You will lead timelines, budgets, and quality while collaborating with senior leadership, study teams, and external partners.

Location options include Warren, NJ, Armonk, NY or Tarrytown, NY with mostly onsite work and hybrid flexibility; you will mentor teams, manage staff, and ensure inspection readiness during regulatory reviews.