Clinical Development, Associate Medical Director, Type 1 DiabetesGeneral Summary: The Clinical Development Associate Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting. In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity. The incumbent may participate in other projects to support the clinical development program.
Key Duties and Responsibilities: Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidanceServes on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study executionParticipates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriateProvides scientific and clinical input to study-related documents and analysis plans including informed consent forms, clinical research forms, statistical analysis plans, clinical pharmacology analysis plans, and clinical study reportsActs as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studiesRepresents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study resultsPerforms other duties as assigned related to other aspects of Clinical DevelopmentKnowledge and Skills: Strong oral and written communication skillsAbility to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriateGlobal clinical research experience and experience interacting with regulatory authorities is a plusWorking familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee/Institutional Review Board review, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical developmentBoard certification/eligibility, as well as clinical training in a relevant medical specialty is highly desiredEducation and Experience: MD, DO or equivalent ex-US medical degree8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experienceCompany 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.
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