Director, Clinical Operations

Role: Lead operational management of Phase 1 clinical studies in healthy volunteers at Alkermes, ensuring compliance with regulatory standards and timely delivery. Responsibilities: oversee study planning, execution, vendor management, and compliance; develop budgets, timelines, and resource plans; support protocol development and risk mitigation; monitor study progress and quality; maintain inspection readiness and documentation; support regulatory submissions and audits; lead and develop Clinical Operations staff. Requirements: B.S., M.S., or Ph.D. in basic sciences; 12+ years in Clinical Operations within biotechnology or pharma; minimum 5 years managing Phase 1 healthy volunteer studies; strong knowledge of GCP, ICH, FDA regulations, and SOPs. Preferred: prior people management experience; expertise in clinical trial operations and regulatory compliance. HighValue: extensive experience in Phase 1 FIH and early development studies, in vivo healthy volunteer trials, GxP standards, and cross-functional collaboration with Clinical Pharmacology, Regulatory, Biometrics, and Quality teams. WorkSetup: hybrid model in Waltham, MA, with 60% in-office, 40% remote; onsite at least 3 days/week.