Senior Director, Regional Pharmacy Operations

Accountabilities • 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>/<800>, 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.

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.

• 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>/<800> 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.

• Ability to spend approximately 60–80% of working time walking, standing, or moving between clinical areas and lift up to 25 pounds.

• Preferred qualifications include Board Certification in Oncology Pharmacy (BCOP), PGY2 residency training in oncology or health-system administration, and Lean Six Sigma certification.

• Experience supporting early-phase oncology research, FDA/EMA or sponsor audits, regulatory horizon scanning, pharmacist residency or academic pipeline programs, and cross-regional pharmacy governance is highly valued.

Benefits

• Annual base salary of $220,000–$230,000 , with actual compensation determined by factors such as market location, job-related knowledge, skills, and experience.

• Eligibility for an annual performance bonus based on individual and organizational results.

• 401(k) retirement savings plan with employer match.

• Generous paid time off and paid holidays.

• Comprehensive medical, dental, and vision coverage, with additional optional insurance options.

• Company-paid life and disability insurance.

• Employee Assistance Program (EAP) providing confidential, no-cost support for employees and their families from day one.

• Flexible FSA and HSA plans to support financial wellness.

• Flexible working environment designed to support balance, well-being, and professional growth.

• Collaborative and inclusive workplace that encourages innovation, continuous learning, shared ideas, and career development.

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