Director, Clinical Development Sciences, Infectious Disease

The Role:

Moderna is seeking a Director to develop, execute and lead clinical studies supporting one or more development programs in the Infectious Disease department. This role will report to one of Moderna’s Executive Directors, Clinical Development, Infectious Diseases and will be the primary point person for clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor monitoring, review and interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners.  

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. The position is based at Moderna’s Cambridge, MA, Princeton, NJ or Bethesda, MD sites. 

Here’s What You’ll Do:

• Provide clinical development expertise and leadership to the clinical study team.

• 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 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.

Here’s What You’ll Bring to the Table:

• MD (or non-US equivalent of MD degree) with completion of residency in Internal Medicine, Family Practice, Geriatrics, Pediatrics or Obstetrics/Gynecology.  

• Alternatively, in lieu of an MD qualification: Advanced degree in Health Studies, Clinical Research Administration, or a related health science discipline from an accredited institution.

• Completion of a Physician Assistant Program with strong clinical experience in vaccines or infectious diseases (including being certified by the National Commission for Certification of Physician Assistants or equivalent, with current licensure as required).

• Minimum of 5 years' experience in clinical research, encompassing early- to late-stage development in an academic or industry setting. Demonstrated ability to:

  • Lead and contribute to the planning, conducting, and oversight of clinical trials.

  • Develop key study documents, contribute to regulatory submissions, and oversee monitoring activities.

  • Collaborate effectively with cross-functional teams, including patient safety, regulatory affairs, clinical operations, quality assurance, data management, and biostatistics.

• Proven track record in leading cross-functional teams and work streams, demonstrating strong interpersonal skills necessary for working closely with CROs, investigators, consultants, and team members across various functions.

• Integrated understanding of FDA, EMA, ICH, and GCP guidelines (with experience in interactions with regulatory agencies) is desirable

• Exceptional written and oral communication skills, capable of meeting the needs of varied audiences and presenting data to internal and external stakeholders.

• Excellent analytical, problem-solving, and strategic planning skills, with a demonstrated ability to deliver high-quality results within established timelines.

• Ability to thrive in a fast-paced environment, demonstrating attention to detail, an internal drive to generate high-quality work, and a sense of passion and urgency to achieve team and program goals.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly