Associate Director, Program Toxicologist, Translational Medicine - Nonclinical Development

Design, execute, interpret, and communicate toxicology strategies supporting the pipeline from discovery through development Partner with Research, CMC, Device, and other cross-functional teams on study plans and design Identify safety-related knowledge gaps and propose risk-mitigation plans Ensure preparation of risk assessments, safety summaries, and technical documents Ensure scientifically rigorous execution of nonclinical studies Support Toxicology Operations with study start-up, execution, and timely reporting of results Develop CRO relationships and support CRO oversight Ensure GLP compliance and appropriate study conduct Travel to CROs to oversee study execution Collaborate with external experts, including pathologists and expert consultants Review clinical study protocols and author relevant IB/Annual Report sections as needed Author regulatory submissions, including nonclinical IND sections, and interact with regulatory agencies Collaborate within TMND on nonclinical strategy and forward-looking plans Prepare written and oral presentations for internal and external dissemination Stay current on the evolving regulatory landscape of cell-based therapies Requirements Ph.D. in relevant field Minimum of 4 years toxicology experience in industry Direct experience partnering with CROs to deliver nonclinical studies, such as toxicology, biodistribution, tumorigenicity, and local tolerability Knowledge of cell therapy space is a plus Neurology and/or ophthalmology experience is a plus American Board of Toxicology (ABT) certification preferred Ability to travel to CRO to oversee study execution Core Competencies Demonstrates expertise in toxicology strategies, including study design, execution, and regulatory submissions, while ensuring GLP compliance and effective collaboration with CROs and cross-functional teams. Highest-signal resume keywords Ph.D. In Relevant Field Toxicology Experience In Industry CRO Partnership For Nonclinical Studies GLP Compliance American Board Of Toxicology Certification ATS Optimization Keywords Hard Skills Toxicology Strategy Design Risk Assessment Preparation Nonclinical Study Execution Technical Document Preparation Regulatory Submission Authoring Soft Skills Collaboration Communication Presentation Skills Certifications & Qualifications American Board Of Toxicology Certification Industry Keywords Cell-Based Therapies Neurology Ophthalmology Biodistribution Tumorigenicity Local Tolerability #J-18808-Ljbffr Jobtailor