Job Category: Clinical: Clinical Operations and Development
Job Number: 2668
Our client is seeking a physician to lead clinical trials for one or more of their development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine, and/or Pediatrics is desirable. Research and industry experience in vaccine development is a plus.
This role will report to the Head, Clinical Development, Public Health Vaccines 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 the client' s Cambridge, MA site.
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 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 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 the clients' 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 organization.
- Represent the client 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 or focused training in Infectious Diseases is desirable.
- 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 and EMA regulatory agencies is desirable.
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