Senior CDM Program Lead: Strategy, Delivery & Compliance

Regeneron Pharmaceuticals, Inc.; New Jersey; Hybrid; USD 180,000 - 235,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Life insurance and disability coverage

Global wellness support

Paid time off

Job summary

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

The role focuses on strategy, governance, and mentorship in a fast-growing environment and offers on-site with hybrid flexibility across Warren, NJ or nearby locations.

Qualifications

• 10+ years in clinical data management in biotech/pharma.
• 5+ years of people management experience.
• Strong knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
• Proven record leading studies and virtual teams.

Responsibilities

• Lead the overall success of CDM deliverables across studies and programs.
• Communicate program status, risks, and issues to collaborators and develop mitigations.
• Provide CDM expertise during protocol design, study start-up, and study conduct with standardized practices.
• Oversee program timelines, resources, and budgets, serving as escalation point for issues.
• Track metrics and KPIs, manage Quality Events, CAPAs, and deviations.
• Represent CDM in reviews, 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 development and performance.

Skills

CDM leadership

Cross-functional leadership

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's degree in Mathematics, Science, or related field

Job description

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

The role focuses on strategy, governance, and mentorship in a fast-growing environment and offers on-site with hybrid flexibility across Warren, NJ or nearby locations.