Director, Investigational Drug Section

Job Title: Director, Investigational Drug Section

Work Location: Miami-Dade County, Florida

Summary:

The Director, Investigational Drug Section is responsible for overseeing all aspects of investigational drug service (IDS) operations at the assigned site, including supervision of pharmacy staff and fulfillment of clinical pharmacist duties. This role ensures compliance with all applicable regulations and standards, manages medication order verification and dispensing, and provides pharmaceutical care to patients and healthcare teams.

Responsibilities:

• Supervise all IDS operations, including medication preparation, dispensing, and documentation, ensuring compliance with regulatory and internal standards.
• Verify medication orders for accuracy, eligibility, and safety, including review of patient consent, laboratory values, and potential drug interactions.
• Oversee and support pharmacy staff, including pharmacists and pharmacy technicians, in daily operations and adherence to double-check verification processes.
• Collaborate with site leadership and study operations teams to maintain high-quality patient care and align workflows and processes.
• Manage drug inventories, including documentation, ordering, receiving, storage, and dispensation tracking for investigational and conventional medications.
• Provide pharmaceutical care, including patient counseling, medication education, and drug information to healthcare teams and patients.
• Review new clinical trial protocols, amendments, and associated documentation, ensuring proper implementation and compliance.
• Maintain investigational documentation, generate reports using IDS drug accountability programs, and ensure accurate medication order entries in electronic medical records.

Qualifications:

• Graduate of an ACPE-accredited School of Pharmacy.
• Current state pharmacist license.
• Previous hospital or clinic pharmacy experience.
• Familiarity with sterile compounding requirements for chemotherapy agents, including USP , USP , and use of laminar airflow hoods or biological safety cabinets.
• Proficiency with Microsoft Office products (Word, Excel, PowerPoint, Access) and electronic medical record/pharmacy software programs.
• 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 Board Certified Oncology Pharmacist (BCOP) preferred.
• Ability to stand and/or walk for 80% of the time, lift up to 25 pounds, and perform occasional lifting, bending, pushing, or pulling.
• Willingness to travel intermittently (less than quarterly) to support new site activation.

Published Category: Clinical Operations & Development