Director of Medical Study Operations

6 days ago


New York, New York, United States Regeneron Pharmaceuticals Full time
Job Title: Director, Medical Study Operations

Regeneron Pharmaceuticals is seeking a highly skilled and experienced Director, Medical Study Operations to join our team. As a key member of our External Sponsored Research (ESR) programs, you will be responsible for overseeing several of our Investigator-Initiated Studies (IIS) and Research Collaborations.

Key Responsibilities:
  • Oversee ESR programs, including IIS and Research Collaborations
  • Manage people, structure, and procedures to support growth
  • Ensure timely deliverables and financial management support
  • Support Investigational and/or Commercialized Products, including non-filing post-marketing research activities
  • Develop a team with growth-minded goals and development plans
  • Ensure efficient alignment with Alliance and internal partners
  • Lead ESR programs compliantly
  • Program planning, allocation, and movement of program budgets, timelines, and program results
  • Supervise budgeting aspects, including annual planning, initial projections, and reforecasts
  • Coordinate drug/material planning, including timing of drug and labeling campaigns
  • Compliance: ESR Processes, FMV, Safety, Regulatory, Training
Requirements:
  • Bachelor's degree required, with 11+ years of active work experience in clinical research, regulatory, or field-based function in pharmaceutical industry
  • Experience in Medical Study Operations required
  • Ability to redirect and create solutions for new regulations or anticipation of updated regulations
  • Science background in therapeutic areas of oncology preferred
What We Offer:

Regeneron Pharmaceuticals is an equal opportunity employer and offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

We are committed to diversity and inclusion and welcome applications from qualified candidates from diverse backgrounds.



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