Director, Investigational Drug Section

Job Title: Director, Investigational Drug Section

Work Location: Allegheny County, Pennsylvania

Summary:

The Director, Investigational Drug Section is responsible for overseeing all aspects of investigational drug service operations at the assigned site, while also fulfilling clinical pharmacist duties. This role involves medication order verification, dispensing investigational and conventional chemotherapy drugs, providing pharmaceutical care, and supervising pharmacy staff. The director ensures compliance with regulations, maintains drug inventories, and supports the effective operation of the pharmacy department.

Responsibilities:

• Supervise all investigational drug service operations, ensuring compliance with local, state, and federal regulations as well as internal SOPs.
• Verify medication orders for accuracy, including dosages, calculations, patient eligibility, and absence of drug interactions.
• Oversee preparation and dispensing of medications, supervising pharmacy technicians and ensuring double-check verification processes.
• Provide pharmaceutical care, including patient counseling, medication education, and drug information to healthcare teams and patients.
• Manage drug inventories, including documentation, ordering, receiving, storage, and dispensation tracking for investigational and conventional medications.
• Assist pharmacy technicians with investigational documentation, weekly inventory, and interactions with study personnel.
• Review new protocols, amendments, and associated forms, and maintain reports using drug accountability programs.
• Collaborate with site leadership and study operations to ensure high-quality patient care and alignment of workflows and processes.

Qualifications:

• Graduate of an ACPE accredited School of Pharmacy.
• Current state pharmacist license.
• Previous hospital or clinic pharmacy experience.
• Oncology pharmacy experience required.
• Familiarity with sterile compounding requirements for chemotherapy agents, USP , USP , and use of laminar airflow hoods or biological safety cabinets.
• Computer proficiency, including Microsoft Office (Word, Excel, PowerPoint, Access).
• Experience with electronic medical record programs, pharmacy software, and study IRT systems.
• Knowledge of Good Clinical Practice (GCP) principles.
• Sterile compounding and chemotherapy certification.
• Intravenous sterile product training.
• Prior experience in clinical trials and management of investigational drugs.
• Specialty residency in oncology and/or current BPS Board Certified Oncology Pharmacist (BCOP) preferred.
• Some leadership experience, preferably with pharmacy technicians.
• Ability to stand and/or walk for 80% of the time, lift up to 25 pounds, and perform occasional lifting, bending, pushing, or pulling.
• Intermittent travel, less than quarterly, to support new site activation.

Published Category: Clinical Operations & Development