Job Description
General Summary :
The Senior Medical Director, T1D (Transplant Immunology / Endocrinology) will define all aspects of T1D translational strategy and will be accountable for delivering key translational milestones.
They will work with cross-functional multidisciplinary teams to define overall translational strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials that will be conducted with these compounds.
Key Duties and Responsibilities :
- Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas
- Participate in design and development of T1D metabolic studies, translational medicine expert working cross functionally with research and other functions to design and implement studies
- Analyze data and develop insights to improve outcomes in T1D transplants, identify potential risks and devise immunosuppression strategies
- Collaborate with cross functional teams, clinicians, and researchers to integrate immunological knowledge into clinical practice and improve patient care
- Participates in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
- Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
- Interfaces with regulatory authorities as appropriate
- Medical Monitors and / or oversees medical monitoring of clinical studies
- Participates in business development and strategic planning activities
- Acts as liaison between clinical development and other internal groups at Vertex for assigned studies
- Provides medical and development leadership for cross-functional teams
- Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
- Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
Knowledge and Skills :
- Experience in the immunological aspects of organ transplantation including but not limited to islet cell transplant, allo transplant and rejection, immune response modulation, and tolerance induction
- Experience in T1D cell therapy, islet cell function / physiology, clinical development is preferred
- Global clinical research experience, and experience interacting 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
- Ability to ensure the completeness of team work
- 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, or the equivalent combination of education and experience
In this Hybrid-Eligible role, you can choose to be designated as :
Hybrid : work remotely up to two days per week; or select On-Site : work five days per week on-site with ad hoc flexibility.
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