Senior Director, Clinical Operations

Role: Senior Director of Clinical Operations overseeing multiple investigational trials in a rare disease development program, with a focus on trial management, vendor oversight, and cross-functional coordination. Responsibilities: manage daily activities of Clinical Trial Managers, oversee CROs and vendors, ensure study milestones and timelines are met, provide strategic input on departmental initiatives, and communicate study progress to senior leadership. Lead alignment with Regulatory, Data Management, Biostatistics, and Pharmacovigilance teams; review budgets, forecasts, and resource allocations; and mentor junior staff. Qualifications: Bachelor’s in life sciences or related field; 12+ years in clinical operations within pharma or CRO, including 6+ years in leadership roles managing Phase I-III global trials. Skills: strong knowledge of GxP, regulatory requirements (US CFR, EU CTD, ICH GCP), excellent communication, project management, risk mitigation, and leadership abilities. Preferred: experience managing multiple phases and global trials; previous line management experience. High-value specifics: rare disease therapeutic focus, global trial management, leadership in complex program oversight, experience with regulatory compliance in clinical research. Work setup: based in San Diego with 10-20% domestic and international travel.