Director, Clinical Operations

Role: Director of Clinical Operations leading global Phase 2/3 clinical trials in a biopharma setting focused on hematologic diseases. Responsibilities: oversee study execution, manage trial managers and vendors, develop and implement clinical strategies, ensure compliance with GCP/ICH and regulatory standards, and track KPIs for timely delivery. Collaborate with medical, regulatory, data, and biometrics teams; contribute to regulatory documentation; and optimize study processes. Requirements: BA/BS, 10+ years of trial management experience within biotech, pharma, or CROs; strong knowledge of clinical development processes, GCP, and global regulations; proficiency in electronic data systems; leadership and communication skills; willingness to travel domestically and internationally. Preferred: experience in orphan indications or oncology. High-Value: leading Phase 2/3 hematology trials, global study oversight, vendor management, and cross-functional collaboration. Work setup: hybrid in Watertown, MA, with travel.