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. 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.
Senior Director, Clinical Development
Location
United States
Posted
1 day ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
The Medical Monitor provides medical oversight and clinical leadership for Phase I–III clinical trials. This individual contributor role is responsible for ensuring subject safety, data integrity, and protocol compliance across assigned studies. The Medical Monitor works closely with the VP, Clinical Development and cross-functional teams to support study design, execution, regulatory submissions, and lifecycle management activities.
Qualifications
- 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.
Requirements
- 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.
Job 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.
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