Director, Clinical Operations

Role: Senior Clinical Trial Manager responsible for strategic planning, financial oversight, and execution of Phase I-IV clinical trials in a biopharma setting. Main objectives: ensure timely, within-budget, high-quality trial delivery while maintaining regulatory compliance and data integrity. Responsibilities: develop clinical trial strategies, oversee CRO/vendor selection and management, manage budgets, and ensure adherence to GCP, ICH, and FDA standards; lead cross-functional teams and external partners; develop and review study documentation; and drive operational efficiencies. Requirements: B.A./B.S. with 8+ years of clinical trial experience in pharma/biotech, expertise in FDA regulations, ICH-GCP, budgeting, and vendor negotiations; strong organizational, communication, and leadership skills; proficiency in Microsoft Office and EDC systems. Preferred: prior experience leading or overseeing clinical trial execution across multiple phases and therapeutic areas. High-value: extensive experience with late-stage trials (Phases I-IV), regulatory compliance, CRO/vendor oversight, and cross-functional collaboration. Work setup: hybrid, onsite in Stoughton, MA, required Tuesdays to Thursdays.