Clinical Development Medical Director, Early Development

Job description

Job Description General Summary: The Clinical Development Medical Director, Early Development 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 early Phases of clinical development (Ph1-Ph 2 PoC), 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 functions and with minimal guidance - Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution - Participates 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, a...