Vice President, Clinical Development

About the Company

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 :   Reporting to the Executive VP, Clinical Development and Medical Affairs, the Vice President, Clinical Development will be responsible for leading strategic development and execution of UroGen’s late phase clinical development programs. Additionally, this person will be responsible for medical oversight (medical monitoring) for early and late phase trials.  The individual will manage clinical operations and collaborate with colleagues from research and development, biometrics, regulatory, pharmacovigilance, quality assurance, medical affairs, business development, and commercial.   They will interpret clinical trial data, together with members of the study team, in the context of emerging external information regarding the relevant treatment and regulatory landscape and provide clinical expertise to support the development program by interacting with external opinion leaders, clinical investigators and regulators.

• MD required
• Postgraduate training / fellowship in urology / urologic oncology preferred
• Development experience in urologic oncology preferred
• Previous management experience required
• Thorough understanding of GCP and international regulations applicable to clinical development
• Track record of designing and interpreting development plans and clinical studies
• Experience leading clinical portions of global regulatory submissions required
• Ability to design, initiate, and conduct clinical studies
• Demonstrated ability to present clinical data, study plans and tactics clearly and accurately to internal and external stakeholders
• Demonstrated ability to approach assigned duties in a highly organized, detailed and accurate manner.
• Ability to work collaboratively with cross-functional colleagues.
• Ability to manage multiple priorities and work in a flexible, dynamic and fast-paced environment.
• Excellent written and oral communication and influence skills, with the ability to inspire confidence and work successfully with varied audiences.
• Lead strategic planning and execution of Clinical Development plans for all late-stage development plans, in collaboration with cross-functional team
• Manage the Clinical Operations team across all UroGen clinical trials
• Act as medical monitor for ongoing clinical trials
• Lead creation and / or contribute to all relevant program documents, including but not limited to   protocols, statistical analysis plans (SAPs),investigator brochures, US and global regulatory submissions and related information requests, abstracts, manuscripts and publications, clinical study reports,      informed consent forms (ICF), case report forms (CRFs), and clinical pharmacology / translational medicine plans
• Participate in planning of publication strategy
• Provide medical input and leadership into early phase development plans and protocols
• Ensure consistent practices with the highest ethical standards in compliance with GCP, local regulations, and UroGen SOPs
• Serve as an advocate for UroGen’s clinical programs both internally and externally, including with the scientific community, key opinion leaders, and regulators
• Manage the late clinical development budget
• Represent the Company in Regulatory Agency inspections and participate in regulatory agency meetings as required.
• Contribute to the evaluation of clinical data and determination of any business risk related to the acquisition of new products.
• Review and provide input on departmental global Standard Operating Procedures (SOPs) and Work Instructions development, audits, and inspection readiness.

We offer a competitive salary, employee benefits, and an excellent work environment.

We are an Equal Opportunity Employer