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 s…
Skills: Investigational drug service, Clinical research, Sterile compounding, Nonsterile compounding, FDA regulations
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$135k–$150k/yr
Full-time
bachelor degree, postgraduate degree
Health insurance, Paid leave, Vacation, Paid holidays, Personal leave, Sick time
Posted 2d ago
Apply by Sep 24
~40 hrs/week
Responsibilities
The Advanced Practice Pharmacist will direct the Investigational Drug Service (IDS) program, providing operational, regulatory, and strategic oversight for clinical trials. They will manage pharmacy resources, ensure compliance with FDA and institutional standards, and supervise IDS personnel to support safe clinical research conduct.
Requirements
Candidates must hold a Bachelor's degree in pharmacy, with a Pharm.D preferred, and possess at least two years of relevant pharmacy experience. A current Maryland pharmacist license in good standing is required, along with demonstrated knowledge of clinical research operations and compounding standards.
Full job description
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.
Benefits Information UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 16 paid holidays, 3 personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).
UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.
Primary 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.
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.
Hiring Range: $135,000 - $150,000, commensurate with education and experience.
UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.
If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request. You may also contact [email protected]. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.
The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.
Maryland's public higher education system, consisting of 12 universities, 3 regional centers, and the USM Office.
Industry
Higher Education
Company size
10,001+ employees
Founded
1988
Headquarters
Baltimore, Maryland
LinkedIn followers
9,840
The University System of Maryland (USM) is the state’s public higher education system. The USM Office works closely with our 12 universities and 3 regional education centers to leverage their collective expertise and resources, share best practices, increase the USM’s effectiveness and efficiency, and advance its mission to improve quality of life in Maryland.
The System employs more than 40,000 faculty and staff across all USM institutions. About 100 employees work in the USM Office, which is headquartered in Baltimore and has locations in Adelphi, Annapolis, and Columbia, MD. To view current employment opportunities at the USM Office, visit: www.usmd.edu/usm/employment/usmojobs
USM Office employees are focused on advancing the USM's 5 strategic priorities with leadership by the USM Chancellor and Board of Regents.
Diversity, Equity, and Inclusion
The USM is one of the most diverse public university systems in the nation and aspires to reflect the full diversity of our state among our students, faculty and staff.
Academic Excellence and Innovation
Providing affordable higher education and increasing student retention and completion rates are among the USM’s top priorities.
Access, Affordability, and Achievement
Serving more than 175,000 students, the USM strives to make higher education accessible to all, including recent high school graduates, transfer students, working adults, and underserved populations. Average in-state tuition and fees for Maryland’s public, four-year institutions remain below the national average.
Workforce and Economic Development
USM institutions address workforce shortage areas, awarding about 14,000 STEM degrees, 3,800 health care degrees, and 2,300 teaching degrees in the 2024-2025 academic year.
Research
USM faculty and staff continue to fuel research and discovery, with about $1.8 billion in research and sponsored programs expenditures in FY 2024.
Offices: 701 E. Pratt St., Baltimore, Maryland 21202, US · 3300 Metzerott Road, Adelphi, MD 20783, US · 9 State Circle, Annapolis, Maryland 21401, US · 10630 Little Patuxent Pkwy, Columbia, Maryland 21044, US