Director, Nonclinical Development - In Vivo Toxicology

UroGen Pharma, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Job summary

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

The role requires leadership across nonclinical feasibility, safety, pharmacokinetics, biodistribution, and efficacy, with collaboration across teams to align with regulatory objectives. The ideal candidate will possess a PhD (or equivalent) and 5+ years in biotech/pharma nonclinical studies, with strong regulatory understanding and experience managing CROs and

Qualifications

• Ph.D. in pharmacology, pathology, or 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 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, 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.

Skills

Nonclinical pharmacology

Project leadership

Regulatory strategy

Data interpretation

Scientific communication

Education

PhD in pharmacology, pathology, or related discipline

PharmD or DVM

Job description

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

The role requires leadership across nonclinical feasibility, safety, pharmacokinetics, biodistribution, and efficacy, with collaboration across teams to align with regulatory objectives. The ideal candidate will possess a PhD (or equivalent) and 5+ years in biotech/pharma nonclinical studies, with strong regulatory understanding and experience managing CROs and