Senior Director, Clinical Operations

Role: Senior Director of Clinical Operations overseeing Phase 3 immunology trials for KT-621 at a biotech specializing in targeted protein degradation. Responsibilities: lead strategic planning and operational execution of late-stage clinical trials, including study design, budget, timelines, enrollment, risk mitigation, and vendor management; collaborate cross-functionally with Clinical Development, Regulatory, Biostatistics, and Leadership; ensure compliance with ICH GCP and regulatory standards; oversee CRO/vendor performance and inspection readiness; contribute to clinical documentation and regulatory submissions; build and develop the clinical operations team. Requirements: BA/BS in health-related field; 12+ years of clinical operations experience in biotech or pharma; proven leadership in high-performing teams; deep knowledge of global regulatory and GxP requirements; strong communication and problem-solving skills; ability to manage multiple priorities in a fast-paced environment. High-Value: late-stage immunology, Phase 3, global regulatory compliance, CRO/vendor oversight, clinical trial planning and execution, experience with INDs, IDRs, and regulatory submissions. WorkSetup: not specified, but implied to be an on-site or hybrid leadership role.