Clinical Development Senior Medical Director, T1D
4 weeks ago
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.
- 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.
- 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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