Principal Pharmacist
About The Position
We are seeking a candidate with clinical research and investigational product experience to provide pharmacy leadership and Principal Investigator-level program leadership for government and commercial clinical trial programs. This individual will be embedded on-site within our existing cGMP clinical trial materials warehouse and will play a key role in supporting current programs, enabling new government contract bids, serving as the accountable Principal Investigator / Project Director for regulated clinical research support programs, and serving as licensed pharmacy leadership for investigational products. This is a programmatic, leadership-oriented position focused on clinical trials, regulatory compliance, quality systems, and operational execution across large, multi-site research programs.
Requirements
- PharmD from an accredited institution
- Active U.S. pharmacist license (state flexible; Missouri licensure preferred or obtainable)
- 5+ years of experience in one or more of the following: Clinical research pharmacy, Investigational drug services (IDS), Clinical trial supply management, CRO, CDMO, or government-adjacent contractor environment
- Demonstrated experience with investigational products in clinical trials
- Familiarity with regulatory frameworks governing clinical trial materials (cGMP, ICH, FDA)
- Demonstrated ability to provide program-level leadership in regulated clinical research environments
Nice To Haves
- Experience supporting NIH, NCI, NIAID, or other federal programs
- Experience with blinded studies
- Experience with international shipment of clinical trial materials
- Experience with sponsor or regulatory audits
- Willing to work in an operational / warehouse-adjacent environment
Responsibilities
- Serve as Principal Investigator (PI) / Project Director with overall responsibility for execution of regulated government and commercial clinical research programs
- Provide licensed pharmacy oversight for investigational products used in clinical trials
- Support proposal development and capture activities for new government and commercial opportunities
- Act as a primary technical authority and subject matter expert during audits, site visits, inspections, and sponsor interactions
- Provide end-to-end leadership for program execution, including coordination with operations, quality, regulatory, and program management teams
- Oversee receipt, storage, labeling, packaging, and distribution of investigational products
- Ensure compliance with cGMP, ICH, FDA / CFR, and Applicable state Boards of Pharmacy
- Support blinded study operations and investigational product accountability
- Provide cognitive pharmaceutical input (protocol review, pharmacy procedures, product handling, stability considerations)
- Work closely with staff, quality and regulatory teams, and scientific and program leadership
- Own and continuously improve pharmacy and investigational product quality systems, including SOP governance, audit readiness, and corrective/preventive actions
- Help maintain, govern, and evolve SOPs related to pharmacy operations and investigational product handling
- Support scaling activities if new contracts are awarded
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What This Job Offers
Job Type
Full-time
Career Level
Principal
