Senior Director, Regional Pharmacy Operations
New
J
JobgetherClinical Research Pharmacy
Based in the United StatesFull-TimeDirector
Salary$220,000–$230,000
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Job Details
- Experience
- 10+ years of progressive pharmacy leadership experience
- Required Skills
- GCP
Requirements
- PharmD or equivalent degree from an ACPE-accredited School of Pharmacy.
- Active and unrestricted pharmacist license in a U.S. state.
- 10+ years of progressive pharmacy leadership experience, including significant direct oversight of investigational pharmacy operations.
- Deep knowledge of investigational drug services, clinical trial protocols, early-phase research, and applicable pharmacy regulations.
- Strong expertise in sterile compounding, hazardous drug handling, chemotherapy preparation, and USP 797/800 requirements.
- Advanced knowledge of GCP, ICH guidelines, regulatory inspection readiness, and clinical research compliance.
- Demonstrated experience applying Lean, Six Sigma, or comparable continuous improvement methodologies.
- Experience owning or co-owning a pharmacy quality management system including SOP governance, deviation management, and CAPA oversight.
- Strong financial and business acumen, including budget management and business-case development.
- Experience with pharmacy automation, EMR platforms, and drug accountability technologies.
- Ability to travel approximately 25–50% to clinical sites.
- Ability to spend approximately 60–80% of working time walking, standing, or moving between clinical areas and lift up to 25 pounds.
Responsibilities
- Provide enterprise-wide leadership and strategic oversight for pharmacy operations across U.S. clinical research sites.
- Design and implement standardized pharmacy workflows covering investigational drug accountability, sterile compounding, and clinical documentation.
- Ensure compliance with FDA regulations, USP 797/800, DEA requirements, and Good Clinical Practice standards.
- Establish pharmacy KPIs and reporting frameworks to monitor performance and drive efficiency improvements.
- Mentor and develop pharmacy leaders across individual sites to strengthen the talent pipeline.
- Lead change initiatives including new-site integrations, technology implementations, and regulatory readiness activities.
- Oversee pharmacy planning for protocol activations, site launches, and clinical volume forecasting.
- Manage pharmacy quality systems including SOP governance, deviation management, and CAPA programs.
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