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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Director Clinical Trial Management Program Operations Leader

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$205k - $341.6k /yr

About the Job

Requirements

  • A bachelor's degree is required; an advanced degree may be considered in lieu of proven experience.
  • At least 12 years of relevant proven experience is required.
  • At least 8 years of experience within clinical operations is required.
  • Knowledge of applicable regulations, International Council for Harmonisation/Good Clinical Practice (ICH/GCP), and standard operating procedures is required.
  • Experience leading complex clinical programs and handling operational strategy, budgets, timelines, and resources is required.
  • Experience forecasting and allocating Clinical Trial Management resources across programs is required.
  • Experience managing Clinical Research Organizations (CROs), vendors, and external partners is required.
  • Experience representing Clinical Trial Management at review committees and governance meetings is required.
  • Experience leading staff recruitment, performance management, development, coaching, mentoring, training, and compliance activities is required.
  • Ability to communicate effectively with senior management, partners, and cross-functional teams is required.

Responsibilities

  • Lead operational strategy and overall delivery for complex clinical programs.
  • Oversee program quality, timelines, budgets, and study team success.
  • Provide operational input to Clinical Study Concepts, feasibility, timelines, and cost estimates.
  • Review plans during protocol design, study startup, and study conduct.
  • Drive decisions, monitor key performance indicators, and implement risk mitigation strategies.
  • Lead vendor selection, contract research organization oversight, governance activities, and partner meetings.
  • Ensure inspection readiness and lead cross-functional support for Regulatory Authority inspections.

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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