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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Director, External Data Acquisition and Delivery

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeWarren, NJ, USA$183.1k - $305.2k /yr

About the Job

Requirements

  • A bachelor's degree in Science, Health, Mathematics, Computing, Information Systems, Data Management, or a related field, with 12 or more years of progressive experience in clinical data acquisition or management and external data operations.
  • At least 5 years of people leadership, including managing managers or senior professionals.
  • Experience leading external data vendor oversight, data transfer specification governance, and external data reconciliation in a regulated environment.
  • Advanced knowledge of ICH-GCP, 21 CFR Part 11, CDISC standards, and EDC platforms such as Medidata Rave, Veeva, or Oracle InForm.

Responsibilities

  • Set the strategic direction for external data acquisition, integration, and reconciliation across all therapeutic areas.
  • Own portfolio-level governance of external data quality, data integrity, and risk.
  • Own and mature the clinical data management model, including qualification, onboarding, operational readiness, ongoing performance monitoring, and governance, in collaboration with the cross-functional team.
  • Guide data transfer specifications, external data management plans, and review plans with cross-functional partners.
  • Set EDC-to-vendor reconciliation standards that keep processes inspection-ready and compliant with ICH-GCP and 21 CFR Part 11.
  • Advance new data capabilities, digital health technologies, and automation with Digital & Tech and Data Technology and Innovation.
  • Lead, coach, and develop a global team of Associate Directors, managers, specialists, and associates.
  • Represent Regeneron in industry forums such as CDISC and SCDM, and deputize for the Global Head as needed.

Desired Qualifications

  • An advanced degree is preferred.
  • Society of Clinical Data Management or ACRP-CP certification is recommended.

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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