Director, Investigational Drug Section

START Center for Cancer Research•Atlanta, GA

About The Position

The Director, Investigational Drug Section oversees all aspects of Investigational Drug Services (IDS) operations at the assigned site while also performing clinical pharmacist duties. These include verifying medication orders, dispensing and documenting investigational drugs, conventional chemotherapy, and supportive care medications. The pharmacist may provide pharmaceutical care by assisting with patient interviews, maintaining current medication lists, educating patients about medications, and providing drug information to patients and the healthcare team. The role operates with a high degree of autonomy, following IDS standard operating procedures and quality-assurance verification guidelines. The director supervises staff responsible for medication preparation and dispensing and IDS operations, and directly supervises all site-specific pharmacy team members, including pharmacists and pharmacy technicians. The position is based in Atlanta, Georgia, with a Monday–Friday schedule from 8 a.m. to 5 p.m. It involves intermittent travel, less than quarterly, to support new site activation.

Requirements

Graduate of an ACPE-accredited School of Pharmacy.
Current state license.
Previous hospital or clinic pharmacy experience.
Familiarity with sterile compounding requirements for chemotherapy agents, USP <797>, USP <800>, laminar airflow hoods, and biological safety cabinets.
Computer skills, including Microsoft Word, Excel, PowerPoint, and Access.
Familiarity with electronic medical record programs, pharmacy software programs, 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.
Ability to stand and/or walk for 80% of work time.
Ability to lift up to 25 pounds and perform some lifting, bending, pushing, and/or pulling.

Nice To Haves

Specialty residency in oncology.
Current BPS Board Certified Oncology Pharmacist (BCOP) certification.

Responsibilities

Partner with the Director of Nursing and study operations leader to maintain efficient, high-quality patient care.
Collaborate with site leadership, shared services leaders, and integration team members to align workflows and processes.
Ensure the IDS space meets local and federal expectations and that operations comply with applicable internal SOPs.
Verify medication orders, including dosages and calculations, patient eligibility criteria, consent forms, laboratory values, required testing, toxicity resolution, and potential drug interactions.
Oversee medication preparation and dispensing from the IDS, including technician supervision and double-check verification before doses are released.
Provide patient medication and supportive-care counseling and drug information to patients and the healthcare team.
Oversee drug inventories and documentation, forecast usage, and manage ordering, receiving, storage, and dispensing records for Phase I and conventional medications.
Assist pharmacy technicians with investigational-drug 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 medication orders accurately in the computer system and maintain accurate patient home-medication information in the EMR.
Directly supervise site-specific pharmacy team members, including pharmacists and pharmacy technicians.
Fulfill clinical pharmacist duties, including medication order verification, dispensing, documentation, and related pharmaceutical care.