Director, Nonclinical Development

UroGen Pharma, Inc•,

8d•Hybrid

About The Position

UroGen is seeking a Director of Nonclinical Development to lead in vivo studies advancing its cancer therapeutic pipeline. The role calls for scientific and operational expertise across nonclinical feasibility, safety, toxicology, pharmacokinetic, biodistribution, and efficacy programs. The Director will collaborate with the nonclinical and translational team to integrate study findings, identify risks, and provide clear recommendations to leadership. As the organization grows, the role may expand to include direct reports. The position works closely with Pharmaceutical R&D, Clinical Development, Medical Devices, Quality, and Regulatory Affairs to align nonclinical plans with clinical and regulatory objectives. The Director will also evaluate new research areas, treatment modalities, indications, and external technologies, and support scientific due diligence for licensing, partnering, and other business development opportunities. Regular in-person work in Philadelphia and travel as needed are expected; remote work is supported.

Requirements

Ph.D. in pharmacology, pathology, or a related discipline, or PharmD/DVM with appropriate experience.
At least five years of relevant biotechnology or pharmaceutical industry experience, with demonstrated expertise in nonclinical pharmacology, pharmacokinetics, and toxicology.
Expertise designing and overseeing outsourced in vivo pharmacology, pharmacokinetic, efficacy, and safety studies, including GLP toxicology for drug development programs.
Expertise drafting nonclinical sections of IND submissions.
Strong understanding of the nonclinical evidence and regulatory requirements needed to advance biologic programs into the clinic.
Ability to interpret multidisciplinary data, manage competing priorities, and communicate clear recommendations to technical and executive audiences.
Strong scientific judgment, project leadership, collaboration, and written and verbal communication skills.
Ability and willingness to work regularly in person in Philadelphia and travel according to need; remote work is supported.

Nice To Haves

Expertise in local drug delivery, oncolytic viruses, virology, immunology, or bioanalytical method development.

Responsibilities

Lead the strategy, design, and execution of in vivo feasibility, safety, toxicology, pharmacokinetic, biodistribution, and efficacy studies.
Translate program objectives into fit-for-purpose study plans, including model and species selection, endpoints, protocols, timelines, and decision criteria.
Select and manage CROs, consultants, and academic partners; oversee proposals, budgets, study conduct, data quality, troubleshooting, and final reports.
Lead GLP toxicology studies and associated toxicokinetic, bioanalytical, and pathology activities in compliance with applicable regulatory standards.
Critically review and integrate nonclinical data, assess program risks, and present evidence-based recommendations to project teams and leadership.
Draft and review nonclinical sections of IND submissions, Investigator's Brochures, regulatory responses, and other development documents.
Collaborate with Pharmaceutical R&D, Clinical Development, Medical Devices, Quality, and Regulatory Affairs to align nonclinical plans with clinical and regulatory objectives.
Evaluate new research areas, treatment modalities, indications, and external technologies.
Support scientific due diligence for licensing, partnering, and other business development opportunities.