Pharmacy Manager, Ambulatory Operations

Pharmacy Manager, Ambulatory Operations

Dell Medical School is seeking a Pharmacy Manager, Ambulatory Operations.

The Manager, Pharmacy is responsible for overseeing the daily operations, clinical quality, regulatory compliance, and financial performance of ambulatory medication management services across a multi-site health system, with a focused scope spanning ambulatory surgery centers (ASC), outpatient clinics, imaging services, and infusion settings. This role serves as a working manager, actively participating in medication operational workflows to ensure safe, compliant, and effective medication management and optimal patient outcomes, while also building the medication management infrastructure and governance framework required to support both current ambulatory operations and future hospital services by bridging current and future-state operations. Reporting to the Chief Operating Officer for Hospital Planning & Operations, the role requires deep expertise in ambulatory pharmacy operations, 340B standards, controlled substance compliance, drug security, regulatory standards, investigational drug services, and clinic-based care delivery, while balancing direct clinical involvement with operational and financial stewardship, including inventory management, purchasing oversight, and quality improvement initiatives. A key strategic priority for this role is the development and implementation of standardized medication management policies across all ambulatory settings, including centralized clinic prior authorization and medication refill management, while establishing scalable, system-wide capabilities that can extend into inpatient and acute care settings. This role also supports the development and oversight of investigational drug services (IDS) for clinical research and trials across Dell Medical School, including the infrastructure, governance, and financial sustainability needed to support the management of investigational products safely and compliantly throughout the study lifecycle. As a working manager, this position leads by example, actively participating in service delivery, ensuring regulatory adherence, and driving continuous process improvement. As the organization grows, additional ambulatory sites and responsibilities will be added, with expansion into hospital services over time.

Responsibilities

Direct Medication Management Operations

• Oversees medication procurement, inventory, and distribution systems for all ASC, clinic sites, and clinical research inventory, maintaining safe and efficient workflows that align with clinic and ASC operations.
• Serves as pharmacist consultant of the ASC site.
• Monitors operational metrics to improve medication access, efficiencies and patient safety.
• Oversees medication management training programs.
• Leads quality improvement and patient safety initiatives including the development and operationalization of a Medication Management Oversight Committee; Identifies and drives process improvement across medication use systems.
• Oversees medication management policies enterprise-wide, including white/brown/clear bagging policy, patient assistance program governance, investigational drug service (IDS), and drug security standards.
• Designs and implements scalable medication-use infrastructure and workflows that can extend beyond ambulatory settings to support future hospital clinical and clinical research operations.
• Defines the scope of IDS services, study acceptance and prioritization criteria, and decision pathways for determining when investigational products must be managed by IDS or through an approved affiliated or external pharmacy.

Ensure Ambulatory and Investigational Pharmacy Regulatory Compliance and Medication Safety

• Ensures compliance with inventory, controlled substance, and chain-of-custody regulations; oversees secure receipt of all pharmaceutical deliveries including direct chain-of-custody verification for controlled substance shipments.
• Tracks compliance with Federal and State regulations, including DEA, state board of pharmacy, USP, and accreditation standards (TJC, CMS) applicable to ASC, ambulatory clinic, pharmacy and imaging environments.
• Serves as primary contact for all HRSA 340B covered entity sites registered.
• Implements 340B clinic and contract pharmacy initiatives, and oversees associated workflows, including inventory replenishment, contract pharmacy, and auditing processes.
• Implements and enforces medication safety policies including multi-dose vial labeling, refrigerated drug temperature excursion response, drug storage security standards, and medication management policies across all ambulatory and clinical research sites.
• Oversees controlled substance management across ASC, ambulatory and clinical research settings, including chain-of-custody receipt, access controls, anesthesia kit oversight, waste reconciliation, and diversion prevention program leadership; serves as the accountable pharmacy leader for DEA compliance in all applicable settings.
• Develops, standardizes, and maintains medication management policies, documentation systems, and audit programs across all ambulatory and clinical research locations; trends controlled substance discrepancy data by provider, drug, and setting to identify patterns and support regulatory reporting obligations.
• Designs regulatory and compliance frameworks that can scale to support future inpatient and hospital operations.
• Tracks medication storage audit findings, controlled substance discrepancy trends, temperature excursion events, and waste reconciliation compliance across all sites.
• Tracks medication errors and adverse drug events and implements corrective actions.
• Supports investigational pharmacy compliance with applicable FDA requirements, ICH Good Clinical Practice, state board of pharmacy requirements, DEA regulations, USP standards, IRB requirements, sponsor or contract research organization requirements, and institutional policies.
• Oversees inspection-ready investigational product records and supports sponsor monitoring, quality assurance reviews, audits, and regulatory inspections, including documentation and corrective actions related to protocol deviations, accountability discrepancies, temperature excursions, or other investigational product issues for products stored within UT Dell ambulatory clinics or departments.

Financial and Business Operations

• Controls pharmaceutical inventory and supply chain costs across ASC and clinic settings; drives consolidation of purchasing to a primary wholesaler and leverages specialty GPO agreements to optimize contract pricing for in-clinic administered specialty drugs.
• Establishes inventory levels and maintains responsibility over inventory management activities in all areas where medication is stored.
• Analyzes financial and operational performance metrics.
• Analyzes medication revenue cycle and reimbursement data for ambulatory and procedural services and implements improvement opportunities.
• Tracks 340B savings and ensures that workflows are compliant with 340B regulations and optimize patient access.
• Negotiates with vendors through GPO agreements and ensures cost-effective sourcing.
• Negotiates agreements for all medication-related equipment and supplies, including 340B contract pharmacies.
• Develops and maintains an IDS fee schedule and study-specific cost estimates for services provided by pharmacy services; supports sponsor budget negotiations and ensures accurate billing, invoicing, and cost recovery for investigational pharmacy services, supplies, equipment, storage, and staff effort.

Collaborate with Clinical, Clinical Research, and Administrative Stakeholders

• Serves as the accountable pharmacy leader for medication management governance across ambulatory and future inpatient settings, partnering with physicians, nurses, compliance, legal, risk management to integrate pharmacy services across ambulatory and future hospital operations, and serving as the pharmacy liaison for provider-controlled substance oversight and credentialing requirements.
• Participates in clinical committees and care coordination initiatives.
• Provides pharmacotherapy expertise and medication guidance.
• Leads pharmacy support and investigational pharmacy services; supports related education and residency programs.
• Reviews clinical trial protocols, pharmacy manuals, and related study documents to identify medication safety, staffing, equipment, space, storage, workflow, technology, and budget requirements for studies involving investigational products.

Strategy and Innovation

• Leads the design of medication management frameworks required for future inpatient and hospital operations, including formulary strategy, medication-use policy design, controlled substance programs, and investigational drug services.
• Leads evaluation and implementation of automated dispensing technologies, including ASC controlled substance management.
• Leads Epic medication management strategy to optimize medication management systems. Supports system-wide clinical protocols, investigational drug, and formulary management.
• Develops longer-term ambulatory clinical services model that optimizes clinical pharmacist support to drive outcomes and support patient access.
• Represents pharmacy services in organizational strategic planning initiatives, including ASC and ambulatory expansion efforts; contributes pharmacy governance infrastructure in preparation for expanded scope with new hospital facility.
• Participates in hospital planning efforts, providing pharmacy input while maintaining focus on current operations.
• Coordinates IDS development with the Clinical Trials Office, IRB, research administration, contracts, compliance, nursing, investigators, clinical departments, Epic, CTMS, and affiliated clinical partners to align research pharmacy services with institutional workflows.
• Partners with Epic, CTMS, and research technology teams to build study-specific workflows for medication ordering, participant assignment, documentation, accountability, billing, and reporting.

Marginal or Periodic Functions:

• Represents the organization during regulatory surveys, accreditation reviews, and external audits.
• Represents investigational pharmacy services during sponsor qualification visits, site initiation visits, monitoring visits, closeout visits, research audits, and FDA or other regulatory inspections.
• Participates in pharmacy residency, student, and professional education programs.
• Supports disaster preparedness, emergency response, and business continuity activities.