Associate Director, Clinical Trial Lead, Clinical Operations

Role: Associate Director, Clinical Trial Lead in clinical operations for a biotech developing cell/gene therapies targeting autoimmune diseases, including SLE and rheumatoid arthritis. Responsibilities: oversee global clinical trials from protocol development through closeout, managing vendors and internal teams; develop trial documents; ensure compliance with ICH-GCP and regulatory standards; monitor budgets and timelines; drive process improvements and remote monitoring strategies; mentor staff and support departmental initiatives. Requirements: BA/BS in a scientific or healthcare field; 8-10+ years of clinical research experience with extensive global trial management in biotech/pharma; proven leadership in complex study oversight, vendor management, cross-functional collaboration; knowledge of early and late-phase development, regulatory requirements, and inspection readiness. Preferred: cell/gene therapy or oncology experience. High-Value: focus on autoimmune disease therapies, early/late-phase clinical development, GxP, vendor oversight, global trial management, remote monitoring, and cross-disciplinary collaboration. WorkSetup: remote; travel up to 10%.