Director, Investigational Drug Section

Essential Responsibilities

• Partner with Director, Nursing and study operations leader to ensure efficient, high quality patient care is maintained and prioritized
• Collaborate with site leadership team, shared services leaders and integration team members to promote alignment in workflows and processes
• Ensure adherence to all local/federal expectations for IDS space and compliance with all applicable internal SOPs
• Verify medication orders including accuracy of dosages and calculations, review of basic patient eligibility criteria, including signed/dated study consent forms, laboratory values within treatment criteria, completed tests, resolution of known toxicity from previous chemotherapy, and absence of serious known drug interactions
• Oversee the preparation and dispensing of all medications from the IDS, including supervision of certified pharmacy technicians during preparation of IV admixtures and oral medication dosages, ensuring compliance with the double-check verification process
• Provide pharmaceutical care including patient medication and supportive care counseling, and drug information to the healthcare team and patients
• Oversee drug inventories including documentation of current inventory, projection of expected usage, ordering, receiving, storage and dispensation tracking of Phase I and conventional medications
• Assist pharmacy technicians in maintaining adequate investigational documentation, records, weekly inventory, and interactions with study personnel
• Review new protocols, protocol amendments and associated forms
• Maintain and generate reports using the IDS drug accountability program
• Contribute to the effective operation of the pharmacy department
• Enter accurate medication computer order entries and maintain reported patient home medications in the EMR

Required Education and Experience

• Graduate of an ACPE accredited School of Pharmacy
• Current State license
• Previous hospital/clinic pharmacy experience
• Familiarity with sterile compounding requirements for chemotherapy agents, USP , USP , laminar airflow hood(s)/biological safety cabinet(s)
• Computer skills including Microsoft Office products (Word, Excel, PowerPoint, Access)
• Familiarity with electronic medical record programs, pharmacy software programs and study IRT systems
• Knowledge of Good Clinical Practice (GCP) principles
• Sterile compounding & chemotherapy certification
• Intravenous sterile product training
• Prior experience in clinical trials and management of investigational drugs

Preferred Education and Experience

• Specialty residency in oncology and/or current BPS Board Certified Oncology Pharmacist (BCOP)

Physical & Travel Requirements

• 80% of time spent standing and/or walking
• Ability to lift up to a 25-pound weight load
• Some lifting and bending, pushing and/or pulling loads
• Intermittent travel, less than quarterly, to support new site activation