Director, Clinical Supplies

About the role

The Director, Clinical Supplies at UroGen Pharma will support our clinical programs through effective planning and execution of complex investigational product and supply for current and future trials. This role is responsible for developing and implementing global clinical supply strategies that ensure uninterrupted supply of investigational products, comparators, delivery kits, and ancillary materials while supporting key development milestones.

Responsibilities

• Develop and execute clinical supply strategies and long-range supply plans across UroGen's development portfolio, ensuring alignment with program timelines, regulatory requirements, and business objectives.
• Serve as the clinical supply functional leader and subject matter expert, providing strategic direction while maintaining hands-on ownership of key clinical supply activities.
• Lead end-to-end clinical supply planning and execution across multiple studies, including forecasting, manufacturing planning, packaging, labeling, distribution, inventory management, and supply continuity.
• Partner with Clinical Development, Clinical Operations, CMC, Regulatory Affairs, Quality, external vendors and other key stakeholders to develop and implement supply strategies that support global clinical trials.
• Establish and drive governance, performance metrics, and risk management processes to support operational excellence, supply continuity, and organizational growth.
• Maintain direct involvement in critical operational activities, including IRT/RTSM oversight, labeling strategy, vendor management, issue resolution, and supply risk mitigation.
• Lead vendor selection, oversight, and performance management.
• Provide strategic recommendations regarding portfolio prioritization, operational readiness, supply risks, and resource planning to support successful study and portfolio delivery.
• Partner with Finance and other stakeholders to develop and manage clinical supply budgets, forecasts, and inventory investments, ensuring effective resource utilization and minimizing waste.
• Ensure clinical supply operations are conducted in compliance with GMP, GCP, GDP, ICH guidelines, FDA regulations, and applicable requirements of global regulatory authorities.
• Support regulatory submissions, inspections, audits, and health authority interactions related to clinical supply activities.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Supply Chain Management, Business, or a related field (Master’s or PMP preferred).
• 7-10 years of progressive experience in clinical supply chain management, clinical operations, or clinical manufacturing within the pharmaceutical or biotech industry.
• Demonstrated experience leading/driving oncology or rare/specialty disease trials is strongly preferred, particularly with Phase 3 programs, global/multi-site studies, or complex formulations (sterile products, hydrogels, biologics, or viral vectors).
• Hands-on expertise with IRT/RTSM systems, demand forecasting, clinical labeling, and vendor management.
• Strong knowledge of GMP, GCP, ICH guidelines, and clinical trial supply regulations (FDA experience required; global experience a plus).
• Strong analytical, problem-solving, communication, and leadership skills, with demonstrated ability to influence cross-functional teams and drive decisions in a dynamic environment.
• Proficiency in Microsoft Office (Excel, PowerPoint) and supply planning tools.