Job description

The Opportunity
Join a dynamic team where your supply chain expertise will directly support groundbreaking uro-oncology trials. This role offers the chance to manage high-value, patient-centric supplies in a fast-paced biotech environment focused on innovative, non-surgical cancer treatments.

Job 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.

Job 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.

Job benefits

We offer a competitive salary, employee benefits, and an excellent work environment.

• Medical
• Dental 
• Vision
• 401k Match
• Paid Time Off
• Employee Assistance Program 

We are an Equal Opportunity Employer