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Provides enterprise-wide leadership and oversight of research pharmacy and IDS across all facilities and aligns services with organizational strategy, clinical research priorities, and patient care objectives. Develops and executes a comprehensive research pharmacy strategy that supports clinical trial growth, service expansion, operational scalability, and integration across care settings. Directs investigational drug operations and ensures compliant and efficient processes for procurement, storage, preparation, dispensing, accountability, reconciliation, and disposition of investigational products. Ensures regulatory and accreditation compliance and maintains accountability for adherence to FDA, GCP, IRB, DEA, USP, Board of Pharmacy, and institutional and sponsor requirements. Serves as the senior subject matter expert for investigational drug services and provides strategic guidance on protocol development, feasibility, medication handling, dosing, blinding, randomization, and risk mitigation. Leads pharmacy integration across the clinical trial lifecycle and ensures alignment with timelines, quality standards, and sponsor expectations from study startup through close-out. Establishes and maintains audit-ready operations and ensures investigational drug records, documentation, and processes meet requirements for inspections and proactively addresses compliance risks. Drives enterprise-wide medication safety and quality programs related to investigational drugs and oversees deviations, adverse events, process failures, and CAPA implementation. Builds, leads, and develops a high-performing research pharmacy organization and supports workforce planning, recruitment, training, competency validation, and leadership development. Provides financial oversight for research pharmacy operations and manages budgets, cost recovery models, fee structures, and resource allocation aligned with trial volume and complexity. Partners with executive and clinical leadership, including investigators, research administration, nursing, pharmacy, and service lines, to integrate pharmacy services into research and patient care delivery. Serves as the primary pharmacy liaison to sponsors, CROs, regulatory agencies, and auditors and supports effective collaboration and enterprise representation. Designs, implements, and standardizes policies, procedures, and SOPs and ensures consistency, scalability, and compliance across the enterprise. Leads research pharmacy technology and data infrastructure initiatives and governs IDS systems, EHR integration, analytics, KPI tracking, and performance reporting to support data-driven decision-making. Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Doctorate degree - Pharmacy (PharmD) required
Certification and Licensing:
Valid State of Florida Registered Pharmacist license required
Refer to department description for applicable certification requirements
Experience:
Minimum 8 years of relevant experience required
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status:
Full time
Employee Type:
Staff
