CDM Program Lead - Senior Associate Director (Hybrid)

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

Job summary

Regeneron seeks an Associate Director, Clinical Data Management, Program Lead to guide strategic CDM activities across assigned clinical programs, ensuring quality, timelines, and budgets are met while collaborating with senior leadership, study teams, external vendors, and collaboration partners.

This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Qualifications

• Bachelor's degree in Mathematics, Science, or a related field
• 10+ years of clinical data management experience in biotech/pharma/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

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

Leadership

Project management

Communication

Problem solving

Education

Bachelor's degree in Math/Science or related field

Tools

CDISC standards

21 CFR Part 11

ICH-GCP guidelines

Job description

Regeneron seeks an Associate Director, Clinical Data Management, Program Lead to guide strategic CDM activities across assigned clinical programs, ensuring quality, timelines, and budgets are met while collaborating with senior leadership, study teams, external vendors, and collaboration partners.

This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.