- Defines a clinical development strategy and prepare the clinical development plans, in conjunction with other relevant functional areas (remove - repeat of sentence above?)
- 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
- 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
- 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
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Clinical Development, Senior Medical Director, T1D Translational Medicine - Boston, United States - Vertex Pharmaceuticals, Inc
Description
Job DescriptionGeneral Summary:
The Senior Medical Director, T1D Translational Medicine (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:
Knowledge and Skills:
Education and Experience:
Hybrid:
work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid#LI-BS1
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
