Pharmacist Advanced Practice - SOM Kahlert Institute

The University of Maryland School of Medicine seeks an experienced Advanced Practice Pharmacist to direct its Investigational Drug Service (IDS). This full-time leadership position provides operational, regulatory, and strategic oversight of the University's IDS program in Baltimore, Maryland, supervising a part-time IDS pharmacist and overseeing operations at the primary IDS and satellite IDS in Catonsville, Maryland.
The Advanced Practice Pharmacist will support a growing portfolio of investigator-initiated and industry-sponsored clinical trials in infectious diseases, psychiatry, substance use disorders, and vaccine development, serving as the pharmacy expert for investigators, study teams, sponsors, and regulatory agencies. This position will play a key role in advancing the School of Medicine's expanding industry-sponsored clinical trials program through exceptional investigational pharmacy services.
The Kahlert Institute for Addiction Medicine brings together leading addiction experts to collaborate and create the synergy necessary for systemic change. University of Maryland School of Medicine faculty scientists serve as an integral part of the Institute. They include neuroscientists studying the brain mechanisms underlying addictions and physician educators working to train a new generation of medical students and residents. They also include clinicians providing a continuum of addiction care with evidence-based harm reduction measures that minimize the negative consequences of drug use on a patient’s overall health.

Responsibilities
- Lead and oversee all Investigational Drug Service (IDS) operations.

- Review clinical research protocols, evaluate study feasibility, assess pharmacy resource requirements, develop pharmacy budgets and negotiate IDS fees as appropriate.

- Develop study-specific procedures for investigational drug preparation, dispensing, accountability, handling, storage, documentation, and record retention.

- Coordinate pharmacy participation in study initiation, implementation, protocol amendments, monitoring visits, audits, and study close-out.

- Ensure compliance with FDA regulations, Good Clinical Practice (GCP), DEA requirements, Maryland Board of Pharmacy regulations, sponsor requirements, and institutional policies.

- Develop, implement, and maintain IDS policies, standard operating procedures, quality assurance activities, and regulatory documentation.

- Oversee sterile and nonsterile compounding of investigational products in accordance with USP standards.

- Manage investigational drug inventory, accountability, returns, destruction, temperature monitoring, and documentation.

- Assist in obtaining and maintaining Maryland pharmacy licensure for the IDS.

- Collaborate with investigators, research coordinators, nursing, and pharmacy staff to support safe and efficient conduct of clinical trials.

- Supervise IDS personnel and provide education to pharmacists, pharmacy learners, investigators, and research staff regarding investigational drug procedures and regulatory requirements.

- Promote continuous quality improvement while expanding IDS capabilities to support the growth of the University's industry-sponsored clinical research portfolio.

Qualifications
Education: Bachelor's degree in pharmacy. Doctoral degree in pharmacy (Pharm.D) preferred.
Experience: Two (2) years of experience in a pharmacy, OR One (1) year post-baccalaureate or post-doctoral/post-graduate pharmacy residency (PGY1) plus one (1) year of experience, OR Two (2) years post-baccalaureate or post-doctoral/post-graduate pharmacy residency (PGY2).
Certification/Licensure: Current Maryland licensure in good standing to practice as a pharmacist or a federal district licensure where the work will be performed upon hire. Certification in a relevant specialty by the Board of Pharmacy Specialties or Commission for Certification in Geriatric Pharmacy Board such as Certified Psychiatric Pharmacist (BCPP) or Board Certified Geriatric Pharmacist (BCGP) eligibility preferred.
Other: Candidates selected for employment may be subject to medical inquiries and/or medical examinations to determine ability to perform the job. Employees in this job class may be subject to pre-employment and random drug testing.· Current pharmacist license in good standing (Maryland licensure or eligibility required).

Knowledge, Skills, and Abilities
Experience with sterile and nonsterile compounding. Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), investigational drug accountability, USP compounding standards, and clinical research operations. Excellent leadership, organizational, communication, and project management skills. Experience in investigational drug services, clinical research pharmacy, or related practice preferred.