Senior Manager, Clinical Operations

Role: Senior Manager, Clinical Operations overseeing Phase 1–3 clinical trials for rare disease therapies, focusing on trial execution and vendor management. Responsibilities: manage internal teams, CROs, sites, and vendors; track trial metrics, timelines, enrollment, and regulatory documents; develop study documents; oversee budgets and supplies; lead cross-functional activities and communicate key issues. Requirements: Bachelor's degree or equivalent; 7+ years in clinical trials with at least 2 years in sponsor or CRO study management; experience in global regulatory standards (US CFR, EU CTD, ICH GCP); preferred experience in Phase 1–3 or international studies. High-Value: involvement in late-stage clinical development, global compliance, biologics or small molecules in rare diseases, with domestic and international travel (~10-20%). Work setup: hybrid remote in San Diego, with onsite requirements and travel.