Regeneron

Associate Director, Clinical Data Management – Program Lead

Regeneron
Posted 10/20/2026full-timeUnited StatesSenior💰 $157,200 - $256,600 per yearWebsite
Apply

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Clinical Data Management, including oversight of deliverables, adherence to regulatory standards, and effective team leadership. Proven ability to manage program timelines, resources, and budgets while ensuring inspection readiness and quality compliance.

Highest-signal resume keywords
Clinical Data Management ExpertisePeople Management ExperienceUnderstanding of 21 CFR Part 11Knowledge of ICH-GCP GuidelinesFamiliarity with CDISC Standards

About the role

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

Requirements

What you’ll need
  • 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
  • 5+ years of people management experience
  • Solid understanding of 21 CFR Part 11
  • Solid understanding of ICH-GCP guidelines
  • Solid understanding of CDISC standards for data collection
  • Proven record of leading studies and study teams
  • Ability to motivate virtual teams in a matrix environment
  • Strong problem-solving, project management, and communication skills in a fast-paced setting

Benefits

Comp & perks
  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life and disability insurance benefits
  • Paid time off
  • Family support benefits
  • Reasonable accommodation during the recruitment process where required

ATS Keywords

✓ Tailor your resume
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Data ManagementProject ManagementMetrics TrackingQuality Event ManagementCAPA ManagementRegulatory Inspection CoordinationProtocol DesignStudy Start-UpStudy ConductBudget Management
Soft Skills
Problem-SolvingCommunicationTeam MotivationMentoringCoaching
Industry Keywords
BiotechnologyPharmaceuticalHealth-Related IndustryMatrix EnvironmentStudy Teams