Investigational Drug Services Manager

Advanced Research Institute is building a Phase 1 clinical research program alongside its established Phase 2–4 research operations. We are seeking a pharmacist with investigational drug services experience to design the Phase 1 pharmacy program, prepare it for first studies, and provide licensed pharmacy leadership as studies begin. The initial engagement is focused on building safe, usable systems before study volume requires a larger team. This position will operate as the Pharmacist-In-Charge (PIC) for the facility. The role may initially operate as fractional, if preferred, but is also open to full time candidates as well. What you will do before the first study Define the investigational drug operating model for ambulatory Phase 1 studies, including which services will be handled on site and which, if any, will use qualified external pharmacy partners. Translate anticipated protocols into pharmacy requirements for access control, storage, temperature monitoring, randomization support, blinding, emergency unblinding, preparation, dispensing, accountability, reconciliation, returns, destruction, and sponsor-authorized disposition. Advise on pharmacy space, cleanroom and controlled-access requirements, equipment, monitoring systems, supplies, vendors and a phased purchasing plan; coordinate with facilities, clinical operations, the laboratory, quality and technology teams. Develop controlled SOPs, forms, logs, checklists and training plans, and training documentation processes for investigational product handling, deviations, temperature excursions, emergency response, chain of custody, staff handoffs and inspection readiness. Assess the licenses, registrations, permits, commissioning, qualification, validation and compounding controls required for the specific pharmacy services ARI elects to offer; identify gaps and support applications and readiness reviews as authorized. Build the staffing and coverage model for startup and early studies, including pharmacist and technician responsibilities, delegation, backup coverage and a proposed approach to residential and after-hours needs. Participate in protocol feasibility, bid defenses, and due-diligence meetings related to pharmacy capabilities and readiness, sponsor qualification and study startup discussions; identify pharmacy constraints, costs, timelines and training needs before ARI commits to a study. Run or support mock workflows, staff training and readiness checks; document gaps and corrective actions before the first investigational product is received or dispensed. Establish pharmacy deviation management, CAPA participation, risk assessments, change control, document control, and pharmacy-specific quality oversight processes and performance metrics. Evaluate and qualify pharmacy-related vendors, including temperature monitoring providers, equipment suppliers, couriers, central pharmacies, and drug destruction services. Establish operational processes for investigational product importation (as applicable), receipt, quarantine, release documentation, temperature-controlled shipping, return shipments, inventory control, and sponsor-directed destruction. Develop sponsor-facing pharmacy capability, facility, equipment, and operational summaries to support qualification and business-development activities. Provide or arrange appropriately licensed on-site pharmacist coverage for authorized pharmacy activities and study dosing, according to the approved protocol, site operating model and staffing plan. Oversee protocol-specific preparation, dispensing, accountability and reconciliation; manage excursions and discrepancies and coordinate their resolution with the principal investigator, study team, sponsor and quality staff. Support sponsor monitoring, audits and inspections; maintain complete, timely pharmacy records and train additional pharmacy personnel as volume grows. Develop a separate plan for residential expansion, including extended-hour coverage and handoffs, if and when ARI approves that stage. Qualifications PharmD or equivalent degree that qualifies the candidate for pharmacist licensure, with an active Utah pharmacist license or ability to obtain one before performing licensed services in Utah. Hands‑on investigational drug services or clinical research pharmacy experience, ideally with Phase 1, first‑in‑human, healthy volunteer or dose‑escalation studies. Demonstrated experience developing pharmacy workflows, SOPs, drug accountability systems, staff training and audit‑ready documentation. Working knowledge of applicable GCP, investigational drug controls, Utah pharmacy requirements and relevant sterile or nonsterile compounding standards for the services actually undertaken. Ability to work across clinical operations, the PI and Medical Director, laboratory, quality, facilities and sponsors; strong judgment about scope, safety, dependencies and readiness. Support dose‑escalation reviews and study safety meetings by providing investigational product accountability, preparation records, dosing documentation, and pharmacy‑related operational input. #J-18808-Ljbffr