Director, Clinical Development, Infectious Diseases - Pediatric Studies

The Role:

Moderna is seeking a Director to lead clinical trials for one or more of their development programs in Infectious Diseases. Board certification in Infectious Diseases and/or Internal Medicine is desirable, and board certification in Pediatrics and/or Pediatric Infectious Diseases is highly desirable.  At least 3 years of research and industry experience in clinical development of vaccines and/or other biological products for infectious diseases is highly desirable. 

This role will report to Moderna’s Therapeutic Area Head, Gastrointestinal Pathogens and Bacterial Vaccines, 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, cross-functional collaboration with relevant team members and other 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 and other products for treatment and prevention of infectious diseases.  Excellence in communication, teamwork, and collaboration is a must. 

Here’s What You’ll Do:

• Provide clinical scientific leadership in the clinical trial team.

• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.

• Either directly monitor 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 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.

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

• MD or non-US equivalent of MD degree with completion of residency in Internal Medicine, Pediatrics, Family Practice, or Obstetrics/Gynecology.  Completion of a fellowship, clinical research experience, or focused training in Infectious Diseases is desirable.

• We can also consider candidates who don’t possess an MD, and may instead possess PhD, PharmD, DO, NP, or PA qualifications. If this is the case, they would also require at least 5 years’ experience of working for a pharma or biotech setting, completing similar tasks.

• Minimum 3 years’ experience in early- to late-stage development in an academic or industry setting.  Proven ability to:

  • Plan and conduct clinical trials

  • Deliver high-quality results within established timelines

  • Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).

• Ability to thrive in a fast-paced environment.

• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.

• Excellent analytical, problem-solving and strategic planning skills.

• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.

• Exceptional written and oral communication skills to meet the needs of varied audiences.

• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA