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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Director, Clinical Data Management

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$183.1k - $305.2k /yr

About the Job

Requirements

  • A bachelor's degree in Mathematics, Science, or a related field, plus a Certified Clinical Data Manager (CCDM) certification.
  • At least 12 years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry.
  • At least 5 years of people management experience.
  • Expert knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards.
  • A proven record of leading studies and study teams, and motivating virtual teams in a matrix environment.
  • Problem-solving, project management, and communication skills, a strategic approach, and the ability to thrive in a fast-paced environment.

Responsibilities

  • Set the data management vision and strategy for one or more therapeutic areas.
  • Ensure high-quality, inspection-ready clinical data.
  • Coach and develop a team of managers and data managers, providing performance feedback and growth opportunities.
  • Oversee portfolio-level execution, track milestones and deliverables, and resolve risks and critical issues.
  • Partner with senior leadership to shape department goals, organizational structure, and resource allocation.
  • Hold CROs and vendors accountable for quality and compliance, and build long-term outsourcing partnerships.
  • Drive inspection and audit readiness, oversee the team through inspections, and resolve quality gaps.
  • Build relationships across teams by negotiating effectively, managing conflict, and collaborating.
  • Sponsor or lead cross-functional initiatives and represent Data Management in program and leadership forums.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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