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Clinical Development Senior Medical Director, T1D

4 months ago

Boston, United States Vertex Pharmaceuticals Full time

Clinical Development Senior Medical Director, T1D (Transplant Immunology/Endocrinology) page is loaded

Clinical Development Senior Medical Director, T1D (Transplant Immunology/Endocrinology)

Apply

locations

Boston, MA

time type

Full time

posted on

Posted 11 Days Ago

job requisition id

REQ-21783

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. #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. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with 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

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Posted 11 Days Ago Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and

transfusion-dependent

beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency

. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit

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. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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