Director, Nonclinical Development

UroGen Pharma, Inc.; Pennsylvania; On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Job summary

UroGen Pharma, Inc. in Philadelphia, PA is seeking a Director of Nonclinical Development to lead in vivo studies advancing our cancer therapeutic pipeline.

You will bring scientific and operational expertise across feasibility, safety, toxicology, pharmacokinetic, biodistribution, and efficacy programs. The role collaborates with nonclinical and translational teams, interprets data, identifies risks, and may include direct reports as the organization grows.

Qualifications

• Ph.D. in pharmacology, pathology, or related discipline, or PharmD/DVM with appropriate experience.
• At least five years of biotechnology/pharmaceutical industry experience with expertise in nonclinical pharmacology, pharmacokinetics and toxicology.
• Experience designing and overseeing outsourced in vivo pharmacology, pharmacokinetic, efficacy, and safety studies, including GLP toxicology.
• Experience drafting nonclinical sections of IND submissions.
• Strong understanding of regulatory requirements to advance biologic programs into the clinic.

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 with 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 related activities in compliance with regulatory standards.
• Critically review and integrate nonclinical data, assess program risks, and present evidence-based recommendations.
• Draft and review nonclinical sections of IND submissions and regulatory documents.
• Collaborate with R&D, Clinical Development, Medical Devices, Quality and Regulatory Affairs to align nonclinical plans with clinical objectives.
• Evaluate new research areas and external technologies.
• Support scientific due diligence for licensing and partnerships.

Skills

Nonclinical pharmacology

Pharmacokinetics

Toxicology

IND submissions drafting

Regulatory requirements

Data interpretation

Prioritization

Communication

Scientific judgment

Project leadership

Collaboration

Written and verbal communication

Travel willingness

In-person work in Philadelphia

Education

Ph.D. in pharmacology or pathology

PharmD or DVM with experience

Job description

Job Description

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.

Position Overview

We are seeking a Director of Nonclinical Development to lead in vivo studies that advance UroGen's cancer therapeutic pipeline. This individual will bring scientific and operational expertise across nonclinical feasibility, safety, toxicology, pharmacokinetic, biodistribution, and efficacy programs.

The Director will partner with other members of the nonclinical and translational team to integrate study findings, identify risks, and make clear recommendations to leadership. As the organization grows, the role may expand to include direct reports.

Job Requirements

• Ph.D. in pharmacology, pathology, or other 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
• Demonstrated expertise designing and overseeing outsourced in vivo pharmacology, pharmacokinetic, efficacy, and safety studies, including GLP toxicology for drug development programs.
• Demonstrated 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.

Preferred Qualifications

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

Job 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.
• Work in close collaboration 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, new treatment modalities, new indications, and new external technologies.
• Support scientific due diligence for licensing, partnering, and other business development opportunities.

Job Benefits

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

• Medical
• Dental
• Vision
• 401k Match
• Paid Time Off
• Employee Assistance Program