Advanced Practice Pharmacist

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).

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 [e-mail]. 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.

Job

Reg or CII Exempt Staff

Full Time/Part Time

Full-Time

Shift

Day Job

Organization

School of Medicine - Kahlert Institute for Addiction Medicine