Clinical Pharmacy Manager - Investigational Drug Service - IDS

Introduction To heal, to teach, to discover and to advance the health of the communities we serve. To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here. Overview The Clinical Pharmacy Manager for the Investigational Drug Service (IDS) is responsible for optimizing drug therapy outcomes for patients enrolled in clinical trials at Montefiore Medical Center. This position plays a critical leadership role in the coordination, oversight, and management of investigational medications, ensuring patient safety and regulatory compliance while supporting clinical research integrity. Through the creative development and implementation of systems, practices, and policies, the IDS Clinical Pharmacy Manager advances the safe and efficient use of investigational agents within the institution. This includes hands‑on leadership of the IDS team, review and implementation of study protocols, and seamless coordination with study sponsors, healthcare providers, regulatory bodies, and IT teams. Responsibilities Leadership & Operations: Lead and manage daily clinical and administrative operations of the Investigational Drug Service. Supervise and train IDS pharmacists, pharmacy technicians, and support staff. Serve as the primary liaison between the pharmacy department and principal investigators, research coordinators, sponsors, and institutional review boards (IRBs). Establish and maintain standard operating procedures (SOPs) for the handling, storage, preparation, labeling, dispensing, and documentation of investigational drugs. Regulatory Compliance & Protocol Oversight: Conduct detailed protocol reviews and assess investigational product requirements. Participate in audits and inspections by internal and external regulatory bodies. Workflow & System Integration: Design and implement practical workflows to support the integration of investigational medications into inpatient and outpatient settings. Collaborate with IT to build research medication orders into electronic health record systems (e.g., Epic). Maintain and enhance IDS tracking systems to monitor drug accountability, storage conditions, and inventory management. Education & Collaboration: Provide training and ongoing education to pharmacy staff, investigators, and clinical teams regarding investigational drug protocols and safe handling practices. Collaborate with multidisciplinary teams to support the initiation, conduct, and close out of clinical trials. Requirements Doctor of Pharmacy (PharmD) degree from an ACPE‑accredited institution required. Valid NYS Pharmacist license and registration is required. PGY1 residency is preferred. Minimum 3–5 years of relevant clinical pharmacy experience, preferably with investigational drug management. Prior experience in a clinical trial or research pharmacy setting strongly preferred. Demonstrated understanding of clinical trial protocol design, investigational drug accountability, and regulatory frameworks. #J-18808-Ljbffr