Executive/Senior Director, Clinical Operations
UroGen Pharma
1 month ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Job Summary
The Executive/Senior Director of Clinical Operations provides strategic and operational leadership for planning, execution, and delivery of clinical studies across multiple development programs. Ensures study strategies, timelines, budgets, and operational plans align with portfolio objectives. Oversees vendor identification, selection, contracting, and performance management; leads review/approval of study documents and operational materials; proactively identifies risks and develops mitigation/contingency plans to ensure high-quality trial execution. Leads cross-functional partnerships with Clinical Development, Biometrics (Data Management), Quality Assurance, CMC, and Medical Affairs. Shapes and matures the Clinical Operations organization by developing scalable processes, governance, and operational infrastructure. Cultivates a high-performing team through mentorship, coaching, professional development, and operational excellence.
Job Responsibilities
- Manage in-house clinical operations.
- Identify and evaluate potential clinical partners (e.g., investigators and vendors).
- Provide strategic input into clinical trial protocol development.
- Provide strategic input into collection and analysis of clinical trial data.
- Establish timelines and budgets for clinical development program delivery.
- Oversee, coach, and develop staff responsible for clinical trial delivery.
- Lead development of contingency/risk management plans focused on GCP-aligned study delivery.
- Lead development and review of Clinical Development processes, systems, and initiatives.
Job Requirements
- Excellent knowledge of Good Clinical Practice (GCP), including global regulatory standards, ethical requirements for protection of human subjects, and inspection readiness.
- Demonstrated experience supporting NDA filings and major global regulatory submissions.
- Minimum 10 years of progressive Clinical Operations experience, including senior leadership with portfolio-level responsibility.
- Proven ability to provide strategic leadership across a clinical development portfolio (timelines, resources, risk, cost).
- Extensive experience leading clinical trials across multiple phases (Phase II/III) and regulatory post-marketing commitments; delivery accountability at program and portfolio levels.
- Demonstrated success building, mentoring, and leading high-performing Clinical Operations teams.
- Strong expertise in planning, forecasting, and portfolio governance; ability to anticipate operational risks and drive mitigation.
- Extensive experience in multicultural/multinational clinical development environments; leadership of global vendors and cross-functional teams.
- Excellent written and verbal communication; ability to influence senior leadership and align stakeholders.
- Master’s or PhD in a scientific discipline (strongly preferred).
Job Benefits
- Medical, Dental, Vision
- 401k Match
- Paid Time Off
- Employee Assistance Program
The Executive/Senior Director of Clinical Operations provides strategic and operational leadership for planning, execution, and delivery of clinical studies across multiple development programs. Ensures study strategies, timelines, budgets, and operational plans align with portfolio objectives. Oversees vendor identification, selection, contracting, and performance management; leads review/approval of study documents and operational materials; proactively identifies risks and develops mitigation/contingency plans to ensure high-quality trial execution. Leads cross-functional partnerships with Clinical Development, Biometrics (Data Management), Quality Assurance, CMC, and Medical Affairs. Shapes and matures the Clinical Operations organization by developing scalable processes, governance, and operational infrastructure. Cultivates a high-performing team through mentorship, coaching, professional development, and operational excellence.
Job Responsibilities
- Manage in-house clinical operations.
- Identify and evaluate potential clinical partners (e.g., investigators and vendors).
- Provide strategic input into clinical trial protocol development.
- Provide strategic input into collection and analysis of clinical trial data.
- Establish timelines and budgets for clinical development program delivery.
- Oversee, coach, and develop staff responsible for clinical trial delivery.
- Lead development of contingency/risk management plans focused on GCP-aligned study delivery.
- Lead development and review of Clinical Development processes, systems, and initiatives.
Job Requirements
- Excellent knowledge of Good Clinical Practice (GCP), including global regulatory standards, ethical requirements for protection of human subjects, and inspection readiness.
- Demonstrated experience supporting NDA filings and major global regulatory submissions.
- Minimum 10 years of progressive Clinical Operations experience, including senior leadership with portfolio-level responsibility.
- Proven ability to provide strategic leadership across a clinical development portfolio (timelines, resources, risk, cost).
- Extensive experience leading clinical trials across multiple phases (Phase II/III) and regulatory post-marketing commitments; delivery accountability at program and portfolio levels.
- Demonstrated success building, mentoring, and leading high-performing Clinical Operations teams.
- Strong expertise in planning, forecasting, and portfolio governance; ability to anticipate operational risks and drive mitigation.
- Extensive experience in multicultural/multinational clinical development environments; leadership of global vendors and cross-functional teams.
- Excellent written and verbal communication; ability to influence senior leadership and align stakeholders.
- Master’s or PhD in a scientific discipline (strongly preferred).
Job Benefits
- Medical, Dental, Vision
- 401k Match
- Paid Time Off
- Employee Assistance Program