Director, Clinical Operations

UroGen Pharma, Inc.; United States; Sur place; USD 180 000 - 230 000; Plein temps

Avantages offerts par ce poste

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Résumé du poste

UroGen Pharma, Inc. is seeking an experienced Director, Clinical Operations, to serve as the Project Director for a large, global Phase 3 clinical study.

The role carries primary operational accountability for study planning, enrollment, budgets, CRO oversight, and quality across countries, sites, and partners. The Director will lead cross-functional operational execution, partner with senior medical and development teams, and ensure coordination across functions, vendors, and geographies.

Qualifications

• Bachelor's or Master's in life sciences or equivalent.
• Minimum 10 years in progressive clinical operations in pharma/biotech.
• Operational lead for large, global Phase 3 study, cross-functional execution, CRO oversight, timelines & budgets.

Responsabilités

• Serve as Project Director for a large global Phase 3 study from planning to closeout.
• Lead cross-functional study team; define responsibilities and decision processes.
• Develop integrated study plans, timelines, enrollment forecasts, and budgets.
• Lead CRO/vendor identification, evaluation, selection, and oversight; drive performance.
• Partner with Finance to manage budgets, forecasts, and change orders.
• Provide Ops input into development plans and protocol feasibility; assess site burden.
• Monitor activation, enrollment, retention; address shortfalls with actions.
• Establish study metrics and reporting; interpret trends and drive resolutions.
• Maintain Trial Master File and inspection readiness; ensure QA alignment.

Connaissances

Clinical operations leadership

Phase 3 experience

CRO oversight

Budget management

FDA/ICH/GCP knowledge

Data management / pharmacovigilance

Leadership & staff development

Communication & negotiation

Travel up to 20%

Formation

Bachelor's or Master's in life sciences

Outils

IxRS/IRT

CTMS

EDC

Description du poste

Job Description

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

Job Summary

UroGen Pharma is seeking an experienced Director, Clinical Operations, to serve as the Project Director for a large, global Phase 3 clinical study. This role will have primary operational accountability for study planning and execution, including timelines, enrollment, budgets, CRO and vendor performance, quality, and inspection readiness. The Director will lead cross‑functional operational execution and partner with the Sr. Medical Director and other key stakeholders on study strategy and decision‑making. Partnering with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Clinical Supplies, Quality Assurance, and Finance, the Director will ensure coordinated execution across countries, sites, and external partners. Prior experience leading a large, complex global Phase 3 study as a Project Director, global study lead, or equivalent is required. Oncology experience is strongly preferred. Urology experience is preferred, but not required.

Job Requirements

• Bachelor's or master's degree in life sciences, or equivalent qualifications.
• Minimum of 10 years of progressive clinical operations experience in the pharmaceutical / biotech industry.
• Demonstrated experience serving as the accountable operational lead for a large, complex global Phase 3 clinical study, with responsibility for cross‑functional execution, CRO oversight, study timelines, budgets, and risk management.
• Experience managing clinical trials across the study lifecycle, including startup, enrollment, ongoing conduct, and closeout.
• Oncology clinical trial experience strongly preferred; urology or uro‑oncology experience preferred, but not required.
• Proven experience selecting and overseeing CROs and other vendors, negotiating vendor and site contracts, and managing study budgets and forecasts.
• Strong knowledge of FDA requirements, ICH guidelines, GCP, ethics requirements, applicable country regulations, Trial Master File management, and clinical trial quality requirements.
• Working knowledge of data management, clinical data review and analysis, and pharmacovigilance; proficiency with IxRS/IRT, CTMS, and EDC systems.
• Demonstrated ability to lead and develop staff, influence cross‑functional teams, and manage external partners across geographies, cultures, and time zones.
• Excellent communication, presentation, negotiation, planning, and problem‑solving skills; ability to prioritize, adapt, and work independently with close attention to detail.
• Ability to travel up to 20%.

Job Responsibilities

• Serve as Project Director and primary operational lead for a large, global Phase 3 study, driving execution from planning and startup through enrollment, study conduct, and closeout.
• Lead the cross‑functional study team, establish clear responsibilities and decision processes, and coordinate activities across internal functions, CROs, vendors, countries, and sites.
• Develop and maintain integrated study plans, ambitious but credible timelines, enrollment forecasts, and budgets; identify dependencies and drive delivery of key milestones.
• Lead CRO and vendor identification, evaluation, selection, and oversight. Establish performance expectations, monitor delivery against scope and milestones, and address performance issues promptly.
• Partner with Finance to manage study budgets, financial forecasts, vendor and site contracts, and change orders, ensuring operational needs and financial commitments remain aligned.
• Provide Clinical Operations input into clinical development plans and protocol design, assessing operational feasibility, study procedures, visit schedules, site and patient burden, and recruitment considerations.
• Lead operational assessments of protocol amendments and incorporate resulting changes into study plans, vendor scopes, training, timelines, and budgets.
• Develop country and site strategies and patient recruitment plans. Monitor activation, screening, enrollment, and retention, and implement actions to address shortfalls.
• Establish study metrics and reporting that make performance, risks, and decisions visible. Interpret trends, develop action plans, and follow through to resolution.
• Identify and mitigate operational risks, maintain contingency plans, and *escalate* issues with clear recommendations and their implications for timelines, quality, and cost.
• Partner with Data Management, Biostatistics, and Pharmacovigilance to support timely data collection, review, analysis, and reporting, and coordinate operational activities supporting database lock.
• Maintain continuous inspection readiness, including a complete and current Trial Master File, appropriate sponsor oversight documentation, and timely resolution of quality issues.
• Ensure study execution complies with UroGen SOPs, GCP, and applicable country requirements. Support audits, inspections, and corrective and preventive actions with Quality Assurance.
• Coach and develop clinical operations staff responsible for study delivery and ensure effective coordination across locations and time zones.
• Contribute to the growth of Clinical Operations by developing practical processes, systems, and infrastructure and applying industry best practices to improve study execution.

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