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Job DescriptionGeneral Summary:The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development and may also participate in other selected projects in clinical development.Key Duties and Responsibilities:Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functionsServes 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 sections of INDs and CTAs, 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 (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR). Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studiesRepresents Vertex to outside medical personal in the development of clinical protocols and study conductPerforms other duties as assigned related to clinical programsKnowledge and Skills:Excellent oral and written communication skillsAbility to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriateEffective at building alliances across functions, based on end-to-end drug development thinking and experienceEducation and Experience:MD, DO or equivalent ex-US medical degreeBoard certification in nephrology is highly desired10+ years equivalent combination of education and experience, with minimum of 2 years of pharmaceutical/Biotech industry experience in clinical development or as investigator for clinical trials, including experience managing clinical trial programs. Background in Nephrology, immunology or autoimmune diseases is highly desirableExperience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study designExperience with design, execution, and analysis of clinical trials requiredAbility to travel up to 25%, domestic and international is desired
