Associate Director – Clinical Operations

Role: Associate Director, Clinical Operations, leading planning and execution of clinical trials across multiple indications from First in Human through Phase III. Responsibilities: develop operational strategies, manage study timelines, budgets, and resources, oversee CRO/vendor selection and performance, ensure compliance with ICH/GCP standards, and contribute to clinical documentation and regulatory submissions. Collaborate with Medical Directors and cross-functional teams, manage data review processes, and represent clinical operations externally. Requirements: Bachelor's in health sciences or related field; 10+ years in global clinical trial operations with at least 4 years managing full trial lifecycle; strong background in oncology or autoimmune/inflammatory diseases; expertise in FDA regulations, ICH/GCP, and vendor oversight. High-Value: experience managing complex multi-indication trials, vendor negotiation, clinical strategy development, and cross-functional leadership. Work setup: hybrid with 70% in Boston; travel approximately 30-40% for site visits, co-monitoring, and international activities.