Director

Description:

Moderna is seeking a physician to develop, execute and lead clinical studies supporting one or more development programs in the Infectious Disease department. Board certification in Infectious Diseases, Internal Medicine and/or Geriatrics, Pediatrics or Obstetrics and Gynecology is desirable. At least 2 years of research and industry experience in vaccine development is highly desirable.

This role will report to one of Moderna’s Senior Directors, Clinical Development, Infectious Diseases and will be the primary point person for the medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review and interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners. The position is based at Moderna’s Cambridge, MA, Princeton, NJ or Bethesda, MD sites.

The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines. Excellence in communication, teamwork, and collaboration is a must.

Here’s What You’ll Do:
 

• Provide clinical development expertise and leadership to the clinical study team.
• Either directly medically monitor clinical trials or provide medical safety oversight of CRO medical monitors.
• Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
• Collaborate closely with partners in the Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Lead the design and writing of clinical protocols and associated clinical documents.
• Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
• Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
• Assume primary responsibility for the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
• Contribute to the writing of manuscripts and publications.
• Comply with Moderna SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparations of materials for Advisory Board meetings.
• Develop and maintain strong, collaborative relationships with the broader Moderna organization.
• Represent Moderna externally to trial site Investigators and administrators.