Clinical Development Associate Medical Director- gMG

Job description

Job Description General 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 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 section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs,...