Associate Director, Clinical Trial Management

Role: Associate Director of Clinical Trial Management responsible for developing and overseeing clinical studies in neuroinflammatory diseases, ensuring compliance with GCP, SOPs, and regulatory standards. Responsibilities include leading multi-site trial execution, vendor management, risk mitigation, and stakeholder collaboration across functional teams such as Regulatory, Legal, and Clinical Development. The role involves developing clinical documents, managing budgets, and maintaining relationships with investigators and key opinion leaders. It requires leading vendor selection, overseeing trial metrics, and ensuring study milestones are met, with up to 30% travel expected. Qualifications: BS/BA in a related discipline, 10+ years in clinical trial operations with direct management experience, preferably in ophthalmology, neurology, or rare diseases. Deep knowledge of FDA, EMA regulations, ICH, GCP guidelines, and experience managing multinational clinical studies. Strong leadership, vendor oversight, and budget management skills are essential. High-value: experience with late-stage, multi-site clinical trials in neuro-inflammatory or neurodegenerative diseases, with familiarity in biologics or small molecules development stages. Collaboration with cross-functional teams and CROs is critical. Work setup: based in Brisbane, CA, with preference for candidates in the San Francisco Bay Area; up to 30% travel.