Global Phase 3 Clinical Operations Director

UroGen Pharma, Inc.; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Job summary

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.

Responsibilities

• 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.

Skills

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%

Education

Bachelor's or Master's in life sciences

Tools

IxRS/IRT

CTMS

EDC

Job description

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.