Clinical Development Senior Medical Director, T1D

4 weeks ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Summary

The Senior Medical Director, T1D (Transplant Immunology/Endocrinology) will lead the development of translational strategies and be accountable for delivering key translational milestones. This role will work closely with cross-functional teams to define overall translational strategy, clinical trials strategy, design, and execution.

Key Responsibilities
  • Develop and implement clinical development strategies and plans in conjunction with other functional areas.
  • Participate in the design and development of T1D metabolic studies, working collaboratively with research and other functions.
  • Analyze data and develop insights to improve outcomes in T1D transplants, identifying potential risks and devising immunosuppression strategies.
  • Collaborate with cross-functional teams, clinicians, and researchers to integrate immunological knowledge into clinical practice and improve patient care.
  • Develop and review study protocols, statistical analysis plans, investigator's brochures, and other key study documents.
  • Prepare regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports, and responses to regulatory authorities.
  • Interface with regulatory authorities as necessary.
  • Provide medical and development leadership for cross-functional teams.
  • Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution and data analysis.
Requirements
  • Experience in the immunological aspects of organ transplantation, including islet cell transplant, allo transplant, and rejection.
  • Experience in T1D cell therapy, islet cell function/physiology, and clinical development is preferred.
  • Global clinical research experience and ability to interact with regulatory authorities is highly desired.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment.
  • Ability to work independently to resolve challenges.
  • Enterprise-wide thinking and ability to work in ambiguity.
  • Excellent oral and written communication skills.
Education and Experience
  • MD, DO, or equivalent ex-US medical degree.
  • Board certification/eligibility in a specialty is highly desired.
  • Transplant Immunologist/Endocrinologist with 12+ years' experience in Immunology/islet cell research, including time managing clinical trials and clinical development programs.


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