Manager, Clinical Supplies

UroGen Pharma; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Job summary

A biotechnology firm in Princeton is seeking a skilled supply chain manager to support uro‑oncology trials. In this role, you will develop supply forecasts for clinical studies, oversee the management of supplies from production to distribution, and collaborate with cross-functional teams to ensure compliance with regulatory standards. Candidates should have 5–10 years of relevant experience, a strong background in oncology trials, and excellent project management skills. This position offers a competitive salary and robust employee benefits.

Qualifications

• 5–10 years of experience in clinical supply chain management or related areas.
• Experience supporting oncology or rare disease trials, especially Phase 3.
• Hands-on expertise with IRT/RTSM systems and clinical supply regulations.
• 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 clinical supply forecasts based on trial timelines.
• Oversee supply activities including planning and distribution.
• Serve as the primary supply chain lead for assigned studies.
• 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 elevate supply risks (shortages, expirations, temperature excursions), 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.

Skills

Clinical supply chain management

Demand forecasting

Vendor management

Analytical skills

Project management

GMP/GCP/ICH

Communication

Project management

Excel

PowerPoint

Education

Bachelor’s degree in Life Sciences, Engineering, Supply Chain Management, Business

Master’s degree or PMP preferred

Tools

Microsoft Office (Excel, PowerPoint)

IRT/RTSM systems

Job description

Job Description

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 elevate supply risks (shortages, expirations, temperature excursions), 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.