Job Description

Senior Director, Lead Medical Reviewer – Global Patient Safety

  • Remote, United States of America
  • Uxbridge, Middlesex, United Kingdom
  • Dublin, Dublin, Ireland

The Sr. Director, Lead Medical Reviewer has the primary responsibility for the oversight of the individual case safety report (ICSR) medical review process for all case level data and aggregate safety data across the Regeneron product portfolio as well as ensuring adherence to quality and compliance metrics. This includes the oversight and management of both internal and external resources provided through third party vendors. This position requires an in-depth understanding of applicable global regulations and the ability to lead and implement effectively functionally within Regeneron, and with vendors and licensing partners externally.

A typical day might look like:

  • Leadership and personnel management of the medical review team in accordance with corporate management standards and policies
  • Provides direction and guidance to all medical review physician resources, ensuring the highest level of case quality and global regulatory compliance.
  • Handles workload within allocated resource and budget to ensure timely completion of deliverables

This role might be for you if:

  • Lead all aspects of and ensure the timely review of safety data, both at individual case level and submission of expedited safety reports and other external submissions through effective processes, systems, and internal staff and vendor management
  • Drive standardization and quality across the ICSR medical review process
  • Act as subject matter expert for a team of physicians supporting the ICSR medical review process
  • Provides leadership for internal and external business initiatives including the generation, review and approval of procedural documents in accordance with applicable regulations in all relevant territories (including SOPs, data conventions/internal guidelines, training documents)
  • Contribute to study management oversight activities to improve the quality and content of medical safety data such as but not limited to queries, investigator site training, support for investigator-initiated studies (IIS), market research programs (MRPs) and patient support programs (PSPs).
  • Ensure effective oversight of internal safety physicians as well as vendor medical review resources including the review of applicable metrics
  • Conduct root-cause analysis of procedural deviations as needed to develop and implement CAPAs (Corrective Action and Preventive Actions) in collaboration with GPS Quality and Compliance and GCP Quality to address late reporting or other deviations
  • Physician (MD or equivalent) is required. Board Certification (if US) is preferred
  • A minimum of 7 years of experience in industry, academia or patient care settings is required (may include Residency training and Fellowship training)
  • Previous experience performing medical review of ICSR and/or safety data required
  • At least 3 years supervisory experience managing direct reports or in a matrix organization with proven proficiency in organizational and planning capabilities

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$216,800.00 – $361,400.00