Senior Director, Regional Pharmacy Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Regional Pharmacy Operations based in the United States.

This executive-level role provides strategic and operational leadership for pharmacy services across a geographically distributed network of clinical research sites.

• Provide enterprise-wide leadership and strategic oversight for pharmacy operations across U.S. clinical research sites, ensuring consistent, compliant, and high-quality practices.
• Partner with executive leadership, site leaders, and clinical operations teams to align pharmacy strategy, resources, and priorities with organizational objectives.
• Design, implement, standardize, and continuously improve pharmacy workflows covering investigational drug accountability, sterile compounding, clinical documentation, and related operational processes.
• Ensure compliance with applicable federal and state requirements, including FDA regulations, USP <797>, DEA requirements, State Boards of Pharmacy, and Good Clinical Practice standards.
• Collaborate with affiliate practices and hospitals on drug procurement processes to streamline workflows, improve coordination, and manage costs effectively.
• Establish pharmacy KPIs, reporting frameworks, and dashboards to monitor performance, identify operational gaps, and drive measurable efficiency improvements.
• Mentor and develop pharmacy leaders across individual sites, strengthening leadership capabilities and building a high-performing, service-oriented talent pipeline.
• Lead major change initiatives, including new-site integrations, technology implementations, process transformations, and regulatory readiness or audit activities.
• Maintain effective relationships with regulatory bodies, vendors, sponsors, partner organizations, and audit teams when required.
• Oversee pharmacy planning for new protocol activations, site launches, capacity requirements, and clinical volume forecasting.
• Serve as a senior subject matter expert in investigational drug management and early-phase oncology clinical trial pharmacy operations.
• Drive cross-regional governance and operational consistency, documenting and managing variations only where local legal or regulatory requirements make them necessary.
• Oversee pharmacy quality systems, including SOP governance, deviation management, CAPA programs, continuous improvement initiatives, and inspection readiness.
• Provide financial leadership through budget ownership, variance management, and business-case development for operational and capital investments.
• Guide pharmacy technology strategy, including evaluation, implementation, optimization, automation, drug-accountability platforms, and EMR integrations.
• Ensure investigational product supply-chain integrity, including cold-chain management, chain of custody, procurement, storage, and regulated drug logistics.

• 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.
• Demonstrated success leading multi-site pharmacy operations, healthcare systems, or similarly distributed clinical environments.
• Strong expertise in sterile compounding, hazardous drug handling, chemotherapy preparation, and USP <797> requirements.
• Advanced knowledge of GCP, ICH guidelines, regulatory inspection readiness, and clinical research compliance.
• Proven ability to lead teams, influence across functions, manage organizational change, and build strong leadership capabilities.
• Experience with pharmacy automation, EMR platforms, drug accountability technologies, and other pharmacy technology solutions.
• Demonstrated experience applying Lean, Six Sigma, or comparable continuous improvement methodologies with measurable operational results.
• 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, variance analysis, and business-case development for operational or capital investments.
• Experience developing KPI frameworks, dashboards, and operational reporting, with the ability to translate data into actionable decisions.
• Knowledge of investigational product supply-chain management, including cold-chain integrity, chain of custody, and regulated drug logistics.
• Excellent communication, collaboration, strategic planning, and stakeholder-management skills across geographically distributed teams.
• Willingness and ability to travel approximately 25–50% to clinical sites and leadership or audit meetings.