Associate Director/Director, Non-Clinical and Translational Research

UroGen Pharma, Inc.; Pennsylvania; On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

PTO

Employee Assistance Program

Job summary

UroGen Pharma, Inc. is seeking an accomplished scientist to serve as Associate Director/Director of Nonclinical and Translational Research. You will lead nonclinical and translational activities supporting oncology programs and contribute to IND submissions.

The role offers in-person collaboration in Philadelphia and potential progression to director level based on experience. The ideal candidate has a Ph.D.

Qualifications

• Ph.D. in cell biology, immunology, or virology or related discipline.
• Expertise in tumor immunology and/or virology.
• At least five years of relevant biotechnology or pharmaceutical industry experience.
• Experience leading nonclinical and/or translational cancer drug discovery or development programs.
• Direct experience drafting nonclinical sections of IND submissions.
• Demonstrated success managing outsourced research relationships.
• Strong understanding of nonclinical studies and regulatory requirements to advance programs into and through clinical development.
• Strong scientific judgement, collaboration, and written and verbal communication skills.
• Ability and willingness to work regularly in person in Philadelphia.

Responsibilities

• Lead nonclinical and translational research activities aligned with program, clinical development, and regulatory objectives.
• Design and oversee in vitro and in vivo studies evaluating mechanism of action, pharmacology, efficacy, and/or biodistribution.
• Select and manage vendors and consultants, including study design, protocol development, data review, troubleshooting, and final reports.
• Lead preparation of nonclinical sections of IND submissions and other regulatory documents and partner with nonclinical safety/toxicology to integrate findings.
• Evaluate clinical pharmacodynamic and predictive biomarker data to assess biological activity, inform dosing regimen and/or patient selection, and guide program decisions.
• Support scientific due diligence and evaluation of licensing, partnering, and other business development opportunities.

Skills

Tumor immunology

Nonclinical/translational leadership

IND submissions drafting

Vendor management

Cross-functional collaboration

Written/verbal communication

In-person collaboration (Philadelphia)

Education

Ph.D. in cell biology, immunology, or virology

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 an accomplished and collaborative scientist to serve as Associate Director/Director of Nonclinical and Translational Research. This individual will lead the development and execution of non-clinical and translational research activities supporting our oncology programs. The successful candidate will bring deep expertise in cell biology, immunology or virology, together with significant biotechnology or pharmaceutical industry experience in the field of Oncology. The position may be filled at the Associate Director or Director level, depending on the candidate's experience and qualifications. As the organization grows, there will be an opportunity to establish internal laboratory capabilities and lead a high-performing research team.

Job Requirements

Required Qualifications

• Ph.D. in cell biology, immunology, or virology or related discipline.
• Expertise in tumor immunology and/or virology.
• At least five years of relevant biotechnology or pharmaceutical industry experience.
• Experience leading nonclinical and/or translational aspects of cancer drug discovery or development programs.
• Direct experience drafting nonclinical sections of IND submissions.
• Demonstrated success managing outsourced research relationships.
• Strong understanding of nonclinical studies and regulatory requirements needed to advance programs into and through clinical development.
• Ability to integrate multidisciplinary data into clear, evidence-based recommendations.
• Strong scientific judgement, collaboration, and written and verbal communication skills.
• Ability and willingness to work regularly in person in Philadelphia.

Preferred Qualifications

• Experience designing and characterizing novel oncolytic viruses and/or other novel therapeutics.
• Experience building laboratory capabilities.

Job Responsibilities

• Lead nonclinical and translational research activities aligned with program, clinical development, and regulatory objectives.
• Design and oversee in vitro and in vivo studies evaluating mechanism of action, pharmacology, efficacy, and/or biodistribution.
• Select and manage vendors and consultants, including study design, protocol development, data review, troubleshooting, and final reports.
• Lead preparation of nonclinical sections of IND submissions and other regulatory documents and partner with nonclinical safety/toxicology to integrate findings.
• Evaluate clinical pharmacodynamic and predictive biomarker data to assess biological activity, inform dosing regimen and/or patient selection, and guide program decisions.
• Support scientific due diligence and evaluation of 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