Director, Clinical Operations

Role: Lead clinical trial strategy and operations for Collegium's biopharmaceutical portfolio, overseeing Phase I–IV trials from planning to completion, ensuring compliance and high-quality delivery. Responsibilities: develop and manage study timelines, oversee CRO and external vendor selection and performance, lead protocol development and regulatory document preparation, and ensure adherence to GCP, ICH, and FDA standards. Drive operational efficiencies, manage budgets and contracts, and promote cross-functional collaboration and team leadership. Requirements: B.A./B.S. with 8+ years in clinical trials within pharma/biotech, strong knowledge of FDA regulations, GCP, and trial management, expertise in budgeting, vendor oversight, and cross-functional communication; proficiency in Microsoft Office and EDC systems. HighValue: extensive clinical operations experience in biopharma, with a focus on late-stage (Ph I–IV) trials, CRO/vendor management, regulatory compliance, and trial execution. WorkSetup: hybrid in Stoughton, MA with onsite presence Tuesday-Thursday.