Global Phase 3 Clinical Operations Director

UroGen Pharma, Inc.; Princeton (NJ); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Job summary

UroGen Pharma is seeking an experienced Director, Clinical Operations to serve as the Project Director for a large, global Phase 3 study. This role carries primary operational accountability for study planning, enrollment, budgets, CRO/vendor performance, quality, and inspection readiness.

The Director will lead cross-functional execution and partner with stakeholders across Regulatory, Data Management, Biostatistics, Pharmacovigilance, and Finance to ensure coordinated global delivery.

Qualifications

• Minimum of 10 years of progressive clinical operations experience.
• Accountable operational lead for a large, global Phase 3 study with CRO oversight.
• Experience across startup to closeout in trials.
• Oncology trial experience strongly preferred; uro-oncology experience preferred, but not required.
• Proven experience selecting and overseeing CROs, vendors, budgets and forecasts.
• Strong knowledge of FDA requirements, ICH guidelines, GCP, ethics requirements, country regulations.
• Working knowledge of data management, data review and pharmacovigilance; proficient with IxRS/IRT, CTMS, and EDC.
• Demonstrated ability to lead staff and manage cross-geography partnerships.

Responsibilities

• Serve as Project Director for a large global Phase 3 study from planning to closeout.
• Lead cross-functional study team across functions, CROs, vendors, countries and sites.
• Develop integrated study plans, timelines, enrollment forecasts, and budgets.
• Oversee CRO/vendor identification, evaluation, selection, and oversight, and monitor milestones.
• Partner with Finance to manage study budgets, forecasts, contracts, and change orders.
• Provide Ops input into development plans and protocol design, assess feasibility and site burden.
• Lead operational assessments of protocol amendments and updates.
• Develop country/site strategies and recruitment plans with activation, enrollment, and retention monitoring.
• Establish study metrics and reporting for risks and decisions.
• Identify operational risks and implement contingency plans and corrective actions.
• Coordinate with Data Management, Biostatistics, and Pharmacovigilance for timely data activities.
• Maintain inspection readiness and study quality documentation.
• Ensure compliance with SOPs, GCP, and country requirements; support audits and CAPAs.
• Coach and develop clinical operations staff across locations and time zones.
• Contribute to process improvements and infrastructure in Clinical Operations.

Skills

Cross-functional leadership

Strategic project leadership

Communication & negotiation

Problem-solving & planning

Travel up to 20%

Education

Bachelor’s or Master’s degree in life sciences

Tools

IxRS/IRT

CTMS

EDC systems

Job description

UroGen Pharma is seeking an experienced Director, Clinical Operations to serve as the Project Director for a large, global Phase 3 study. This role carries primary operational accountability for study planning, enrollment, budgets, CRO/vendor performance, quality, and inspection readiness.

The Director will lead cross-functional execution and partner with stakeholders across Regulatory, Data Management, Biostatistics, Pharmacovigilance, and Finance to ensure coordinated global delivery.