Manager, Clinical Supplies

UroGen Pharma, Inc•,

51d

About The Position

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We are fundamentally changing the way patients are treated for urologic cancers. Watch our New Horizons in Bladder Cancer event and discover why it’s an exciting time to join UroGen Pharma. Join us and be part of the team that will redefine the future of urological cancer treatment. Behind every UroGen innovation is the inspiration to empower uro-oncology patients with life-changing treatments. At UroGen, our people are our greatest asset. We cultivate a culture built on collaboration, creativity, and continuous growth. UroGen is a dynamic, rapidly expanding organization with an unwavering focus on improving the lives of patients because they deserve better.

Requirements

Bachelor’s degree in Life Sciences, Engineering, Supply Chain Management, Business, or a related field (Master’s or PMP preferred).
Minimum 5–10 years of progressive experience in clinical supply chain management, clinical operations, or clinical manufacturing within the pharmaceutical or biotech industry.
Demonstrated experience supporting 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).
Excellent analytical, problem-solving, communication, and project management skills; ability to thrive in a dynamic environment.
Proficiency in Microsoft Office (Excel, PowerPoint) and supply planning tools.

Responsibilities

Develop, maintain, and execute clinical supply forecasts and demand plans based on study protocols, enrollment projections, and trial timelines for Phase 3 and early-phase uro-oncology studies.
Oversee end-to-end supply chain activities, including production planning, packaging, labeling, and distribution of UroGen formulations, comparator products, delivery kits, and ancillary supplies in coordination with CMOs and vendors.
Serve as the primary supply chain lead for assigned studies; actively participate in cross-functional team meetings with Clinical Operations, CMC, Regulatory, Quality, and Medical Affairs.
Manage Interactive Response Technology (IRT/RTSM) systems, including design, user acceptance testing, and ongoing oversight to support open label, blinded, or complex trial designs.
Develop and approve clinical labels in collaboration with Clinical Operations, Regulatory Affairs, Manufacturing & Supply Chain, Pharmaceutical Development, and Quality Assurance.
Identify, mitigate, and escalate supply risks (e.g., shortages, expirations, temperature excursions) while implementing contingency plans to avoid trial delays.
Manage temperature excursions (in storage/in distribution) for clinical supplies.
Monitor vendor performance (packaging, labeling, distribution) against KPIs and budget; drive continuous improvement in supply processes with emphasis on waste minimization for high-value materials.
Ensure full compliance with GMP, GCP, ICH guidelines, and UroGen quality standards in work processes and the management of clinical supplies.
Track supply-related expenses and contribute to regulatory submissions and inspections as needed.