Global Phase 3 Clinical Operations Director

UroGen Pharma, Inc.; Northern (KY); Sur place; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Résumé du poste

UroGen Pharma is seeking an experienced Director of Clinical Operations to serve as the Project Director for a large, global Phase 3 clinical study. This role will oversee planning, enrollment, budgets, CRO/vendor performance, quality, and inspection readiness, partnering with senior medical directors and other stakeholders.

The ideal candidate has 10+ years in clinical operations, oncology/uro-oncology experience preferred, and a track record of leading complex global trials across geographies

Qualifications

• Bachelor’s or Master’s degree in life sciences or equivalent.
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• Minimum of 10 years of progressive clinical operations experience in pharma/biotech.
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• Experience leading a large global Phase 3 study as Project Director or equivalent.
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• Oncology/uro-oncology experience preferred, but not required.
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• Experience selecting/overseeing CROs and vendors; budgeting and forecasting.

Responsabilités

• Serve as Project Director and primary operational lead for a large global Phase 3 study.
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• Lead cross-functional study team and coordinate activities across functions, CROs, vendors, and sites.
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• Develop integrated study plans, timelines, forecasts, and budgets.
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• Oversee CRO/vendor identification, selection, and performance.
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• Manage study budgets and change orders with Finance.

Connaissances

Project leadership

Cross-functional leadership

Vendor management

Budget management

GCP/ICH knowledge

Data management

Global study leadership

Communication skills

Formation

Bachelor's or Master's in life sciences

Outils

IxRS/IRT

CTMS

EDC systems

Description du poste

UroGen Pharma is seeking an experienced Director of Clinical Operations to serve as the Project Director for a large, global Phase 3 clinical study. This role will oversee planning, enrollment, budgets, CRO/vendor performance, quality, and inspection readiness, partnering with senior medical directors and other stakeholders.

The ideal candidate has 10+ years in clinical operations, oncology/uro-oncology experience preferred, and a track record of leading complex global trials across geographies