Overview/Purpose of Position:
The Senior Research Pharmacist is the senior clinical and operational leader for the CDCRC's Investigational Drug Service (IDS) and USP-compliant sterile and hazardous drug compounding unit. The pharmacist establishes, operates, and continuously improves a high-performing IDS within a new 1,079 sq ft pharmacy suite designed to USP 797/800, California Board of Pharmacy, and California Building Code standards. The role ensures safe, compliant, and efficient support for Phase I-IV clinical trials, including advanced therapy medicinal products (ATMPs), gene and cell therapies, and complex sterile compounding, while leading quality systems, inspection readiness, and multidisciplinary collaboration.
Essential Functions
Investigational Product (IP) Management and Trial Support
- Provide end-to-end IP oversight (feasibility through close-out/archival) for sponsor- and investigator-initiated studies, device-drug combinations, pediatric/adult oncology, vaccines, intrathecal, chemotherapy, and gene/cell therapies.
- Author and maintain protocol-specific pharmacy manuals; manage randomization/blinding, unblinding, temperature excursion plans, and IP chain-of-custody across ambient, refrigerated, frozen, and cryogenic conditions.
- Coordinate with IRT/IWRS; maintain audit-ready accountability and records.
Program Leadership and Development
- Stand up and lead IDS operations: service catalog, staffing model, training plan, SOP framework, quality management system (QMS), KPIs/dashboards, audit schedules, and cost-recovery models.
- Lead cleanroom commissioning/qualification (IQ/OQ/PQ), media fills, smoke studies, and environmental monitoring.
Compounding and Dispensing (Sterile/HD/Non-sterile)
- Perform sterile compounding per USP 797 ISO Class 7 standards; hazardous drug handling per USP 800; non-sterile per USP 795.
- Verify identity and integrity of ATMPs (e.g., viral vectors, cellular therapies); prepare per protocol and IRB-approved orders.
Quality Systems, Compliance, and Safety
- Maintain SOPs, work instructions, forms, logs; implement QMS including incident reporting, CAPA, deviation/exception management, and continuous improvement.
- Ensure compliance with FDA/ICH-GCP, Joint Commission, state/federal laws, privacy and data integrity standards; maintain inspection readiness.
Collaboration and Stakeholder Engagement
- Serve as SME and liaison with investigators, clinicians, coordinators, nurses, IRB, IBC, EHS, Office of Research Administration and Clinical Trials and Industry Agreements..
- Participate in sponsor/monitor visits, audits, and regulatory inspections; present findings and corrective actions.
Education, Training, and Leadership
- Mentor pharmacists/technicians; oversee onboarding, competency assessments (e.g., aseptic technique, HD handling), and ongoing GCP/GLP/GMP training.
- Represent IDS in governance committees and external collaborations.
Non-Essential Functions
- Special projects, research/quality improvement initiatives, formulary/shortage mitigation, presentations, publications, and professional committee participation.
- Shared on-call coverage per rotating schedule.
Basic Duties and Responsibilities
- Coordinate all aspects of IDS operations: drug receipt, quarantine, verification, segregation, secure storage, dispensing, return/destruction per sponsor requirements, and documentation.
- Maintain systems for inventory control, expiry checks, environmental/temperature monitoring, and excursion response.
- Develop and enforce policies/SOPs for storage, preparation, distribution, and control of IP, including narcotic/controlled substance oversight and reconciliation.
- Conduct feasibility and coverage analyses; contribute to budgets and cost-recovery models; support timely study start-up and site activation.
- Conduct SIVs; write study-specific procedures; maintain study files; ensure protocol compliance and patient safety.
- Provide accurate, timely investigational drug information to clinical teams; support Cerner or equivalent EHR verification processes.
- Maintain a safe, clean, and orderly work environment; ensure unidirectional workflow and appropriate gowning, PPE, and biosafety practices.
Minimum Education Requirements
- Doctor of Pharmacy (PharmD) or equivalent from an accredited school of pharmacy required.
- Postgraduate training: PGY1 residency required; PGY2 (Oncology, Pharmacotherapy, Health-System Pharmacy Administration and Leadership, or related) preferred. Equivalent advanced practice experience may be considered.
Communication Requirements
- Excellent written and verbal communication required, including:
- Clear authorship of pharmacy manuals, SOPs, and training materials.
- Effective communication with sponsors/monitors, regulators, IRB/IBC, and multidisciplinary teams.
- Skilled presentation of audit/inspection findings, metrics, and corrective actions to leadership.
Licenses, Certifications, Accreditation, and Specialized Knowledge
- Current, active pharmacist license in the State of California (CA DCA) required.
- BLS certification required per institutional CPR/Code Blue policy.
- Preferred certifications: Board certification (Board Certified Oncology Pharmacist (BCOP); Board Certified Specialized Clinical Pharmacist (BCSCP), Board Certified Pharmacotherapy Specialist (BCPS), or equivalent); Sterile Compounding Certification; Aseptic media-fill/gloved fingertip testing competency; USP 800 HD handling competency.
- Demonstrated knowledge of:
- USP 797/800/795; California Board of Pharmacy regulations; California Building Code for compounding spaces.
- FDA regulations (21 CFR), ICH-GCP, Joint Commission standards, IBC/IRB processes, NIH biosafety guidance for recombinant/synthetic nucleic acid research.
- GxP principles (GCP/GLP; familiarity with GMP interfaces for ATMPs).
- IRT/IWRS, temperature and environmental monitoring systems, and chain-of-custody controls.
Minimum Job-Related Experience
- Minimum 10-15 years of experience in hospital/clinical pharmacy with direct IDS responsibilities and sterile/HD compounding; 5-7 years preferred for senior-level leadership.
- Experience launching or leading IDS programs, including building SOPs, QMS/CAPA, and KPI dashboards.
- Demonstrated experience with complex trials (oncology, vaccine, intrathecal) and advanced therapies (gene/cell therapy; viral vectors such as AAV/lentivirus; oligonucleotides; "N-of-1"/personalized therapeutics).
- Experience with eHR verification, drug accountability systems, and audit/inspection readiness.
Professional Affiliations (preferred)
- Active involvement with professional organizations such as: ASHP: American Society of Health-System Pharmacists (including Investigational Drug Services Section); HOPA: Hematology/Oncology Pharmacy Association; ACRP: Association of Clinical Research Professionals; SOCRA: Society of Clinical Research Associates; ISPE: International Society for Pharmaceutical Engineering; ISCT: International Society for Cell & Gene Therapy or equivalent.
Knowledge, Skills, and Abilities (KSAs)
Technical/Regulatory:
Mastery of USP 797/800 aseptic technique, HD handling, beyond-use dating, and environmental monitoring.
Proficiency in ICH-GCP, FDA/21 CFR, IRB/IBC workflows, and biosafety for ATMPs.
Strong IP accountability, blinding/randomization, and documentation practices; audit-proof recordkeeping.
Operational/Quality:
QMS development and execution (deviations, root cause analysis, CAPA, change control, risk assessment/FMEA).
Cleanroom lifecycle management (design review, IQ/OQ/PQ, media fills, smoke studies).
Inventory management across ambient/refrigerated/frozen/cryogenic; temperature excursion investigations.
Leadership/Collaboration:
Program-building, project management, and resource planning; budget and cost-recovery acumen.
Ability to lead through inspections and cross-functional initiatives; high reliability mindset.
Communication/Interpersonal:
Exceptional clarity in protocol interpretation and translation to pharmacy practice.
Effective educator and mentor; confident presenter to sponsors, auditors, and senior leadership.
Digital/Systems:
Competence with Interactive Response Technology / Interactive Web Response System(IRT/IWRS), Electronic Trial Master File(eTMF)/ Electronic Investigator Site File( eISF)interfaces, Electronic Health Record (eHR), barcoding, and data/reporting tools.
Familiarity with environmental monitoring systems and validated temperature monitoring platforms.
Work Conditions/Other Requirements
- On-site role within USP-compliant cleanroom and ante areas; adheres to gowning, PPE, and biosafety requirements.
- May require rotating on-call availability, occasional evening/weekend work to support protocol needs, and participation in sponsor/regulatory inspections.
- Ability to lift up to 25 lbs and handle cryogenic/frozen shipments per safety procedures.