Associate Director, Clinical Quality

About the Company

Uro Gen 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 Uro Gen® Pharma. Join us and be part of the team that will redefine the future of urological cancer treatment.

Behind every Uro Gen innovation is the inspiration to empower uro-oncology patients with life-changing treatments. At Uro Gen, our people are our greatest asset. We cultivate a culture built on collaboration, creativity, and continuous growth. Uro Gen is a dynamic, rapidly expanding organization with an unwavering focus on improving the lives of patients because they deserve better

The Associate Director Clinical Quality is a key role responsible for developing, implementing, and managing the Quality aspects of company’s clinical development. This individual will ensure that clinical activities, including those conducted by outsourced partners, comply with Good Clinical Practice (GCP) regulations, internal Standard Operating Procedures (SOPs), and relevant national and international standards.

• This is a full-time hybrid position. At least once a month onsite at Uro Gen offices in Princeton.
• Travel will be required for clinical sites visits/audits, vendor audits, and other business needs.

• Minimum of 5-7 years of experience in Clinical Quality Assurance, preferably in a pharmaceutical or biotech setting with outsourced trials.
• Strong understanding of U.S. and international regulatory requirements for clinical trials, including ICH E6(R2), 21 CFR Parts 50, 54, 56, and 312.
• Proven experience in auditing CROs and other clinical vendors.
• Demonstrated experience in preparing for and participating in regulatory agency inspections.
• Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced, dynamic environment.
• A proactive and strategic mindset with a focus on risk mitigation and process improvement.
• Excellent interpersonal relations, ability to connect and work independently.
• Effective verbal and written communication skills, with the ability to influence and collaborate with diverse stakeholders.
• Fully fluent in English (spoken, written).
• Experience in electronic Quality Management Systems.
• Experience in technical and SOP writing.
• Microsoft Office full proficiency (Word, Excel, PowerPoint).

• Bachelor's degree in a life-science or health-related field.
• Advanced degree or certification in Quality Assurance is a plus (e.g., RQAP-GCP).

• Serve as the primary QA point of contact for clinical activities.
• Ensure quality assurance support to clinical development in accordance with GCP regulations.
• Participate in preparation/review/approval of study specific plans.
• Join sites monitoring visits.
• Collaborate with Clinical Department and external vendors and contract research organizations (CROs) to monitor trial performance, perform site audits, and address any quality deviations promptly.
• Collaborate with Clinical Operations, Regulatory Affairs, and Data Management to ensure quality throughout the clinical trial lifecycle.
• Lead the handling of clinical quality complaint issues, including investigations.
• Perform any other related duties as management may require from time to time.

• Participate in the evaluation, qualification, and selection of CROs and other clinical vendors, including clinical vendor audits to ensure compliance with quality agreements, GCP, and other applicable regulations.
• Participate in vendor performance evaluation…