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 acomprehensive benefits packagethat prioritizes wellness, work/life balance, and professional development, along withadditional exciting perksthat 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 aUMB Job Applicant Accommodation Request. You may also contactleaveandaccom@umaryland.edu. 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 theUMB Notice of Non-Discriminationfor more information. Job: Reg or CII Exempt StaffOrganization: School of Medicine - Kahlert Institute for Addiction Medicine Title: Advanced Practice Pharmacist Location: null Requisition ID: 260000XE
