Sr. Director, Clinical Development (Medical Monitoring)

UroGen Pharma, Inc•,

76d•Onsite

About The Position

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.

Requirements

MD/DO.
4–8+ years of industry experience in biotech, pharma, or CRO, including hands-on medical monitoring responsibilities.
Experience across Phase I–III oncology trials; comfort working autonomously in a lean organization.
Background in Urology/ Uro‑Oncology (strongly preferred) or other solid tumor indications.
Strong understanding of GCP, clinical trial methodology, and safety surveillance.
Experience contributing to NDA/BLA submissions.
Excellent communication skills for direct interaction with investigators, KOLs, regulators, CRO partners, and internal stakeholders.
High adaptability and resourcefulness typical of small-company, highly visible, high-ownership environments.
Post-residency clinical experience strongly preferred.
Comfort functioning as an individual contributor with significant ownership and minimal infrastructure.
“Roll-up‑your‑sleeves” mindset and willingness to take on operational and strategic tasks as needed.
Rigorous clinical judgment and sharp scientific reasoning.
Ability to influence cross-functionally without formal authority.
Strong organizational skills and ability to manage multiple simultaneous studies.

Nice To Haves

Background in Urology/ Uro‑Oncology (strongly preferred)
Post‑residency clinical experience strongly preferred

Responsibilities

Serve as Medical Monitor for multiple concurrent studies with a fully hands-on approach to patient safety, data review, and protocol compliance.
Independently lead medical data review activities and safety analyses with cross-functional partners.
Develop or co-own protocol concepts, synopses, full protocols, medical monitoring plans, and study documentation.
Provide direct clinical training to internal teams, CRO partners, and investigators as the primary medical point of contact.
Drive consistency, rigor, and responsiveness in medical oversight throughout study execution.
Contribute substantively to regulatory documents including IND/CTA components, IBs, DSURs, clinical study reports, and key elements of the upcoming NDA filing.
Participate in preparing for regulatory interactions where hands-on medical input is required.
Work closely with Clinical Operations, Early Clinical Development, Data Management, Biostatistics, Regulatory, Safety, Quality and Medical Affairs.
Represent Clinical Development in investigator meetings, expert/KOL discussions, partner collaborations, and CRO touchpoints.
Take ownership of solving problems rapidly and collaboratively, consistent with the culture of a small biotech environment.
Provide clinical insight into lifecycle management of oncology assets, including exploratory strategies, label-expansion thinking, and evidence needs.
Support business development through hands-on scientific due diligence, feasibility evaluation, and risk-benefit assessment.