Lead Advanced Practice Pharmacist: Investigational Drug Service

University of Maryland, Baltimore (UMB); Baltimore (MD); On-site; USD 135,000 - 150,000; Full time

Benefits offered by this job

Pension plan / ORP

Paid leave (4+ weeks) and holidays

Health insurance

Tuition remission for employees and/or

Flexible work schedules / teleworking

Job summary

The University of Maryland School of Medicine seeks an experienced Advanced Practice Pharmacist to direct its Investigational Drug Service (IDS) in Baltimore, MD. This full-time leadership role provides operational oversight, regulatory compliance, and strategic development of the IDS program, supervising a part-time IDS pharmacist and coordinating across main and satellite IDS locations.

The ideal candidate will oversee investigational drug preparation, documentation, budgeting, and quality

Qualifications

• Maryland licensure in good standing is required.
• Experience with regulatory requirements for clinical trials.
• Leadership experience overseeing IDS or pharmacy operations.

Responsibilities

• Lead and oversee all IDS operations.
• Review protocols, assess resources, budgets, and negotiate IDS fees.
• Develop study procedures for investigational drug prep, handling and documentation.
• Coordinate IDS participation across initiation, amendments, audits, and close-out.
• Ensure compliance with FDA, GCP, DEA, and state regulations.
• Develop, implement, and maintain IDS policies, SOPs, QA, and regulatory docs.
• Oversee sterile/nonsterile compounding per USP standards.
• Manage IDS inventory, accountability, and temperature monitoring.
• Assist in Maryland licensure for IDS.
• Collaborate with investigators, coordinators, nursing, and pharmacy staff.
• Educate staff on IDS procedures and regulatory requirements.
• Promote QA and expand IDS capabilities.

Skills

Leadership

Regulatory compliance

GCP

FDA regulations

Pharmacy operations

Clinical research

Investigational drugs

Communication

Education

Pharm.D preferred

Pharmacy degree (B.S. or PharmD)

Job description

The University of Maryland School of Medicine seeks an experienced Advanced Practice Pharmacist to direct its Investigational Drug Service (IDS) in Baltimore, MD. This full-time leadership role provides operational oversight, regulatory compliance, and strategic development of the IDS program, supervising a part-time IDS pharmacist and coordinating across main and satellite IDS locations.

The ideal candidate will oversee investigational drug preparation, documentation, budgeting, and quality