Director, Toxicology and Translational Sciences

Who we areREGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.The opportunity As the Director of Toxicology and Translational Sciences, you'll play a pivotal role in shaping the future of groundbreaking therapies by evaluating the safety and translational profile of cutting-edge drug candidates. You'll ensure our development programs provide invaluable scientific expertise across non-clinical development, guiding products from discovery all the way through clinical trials. A major aspect of this role is creating strategic, impactful non-clinical plans to support critical regulatory submissions, including pharmacological and safety assessments.What you'll be doingServe as key representative on Core Teams for non-clinical safety and translational sciences.Provide strategic leadership for pharmacology, toxicology, and clinical translation strategies.Collaborate cross-functionally to develop non-clinical strategies for first-in-human trials.Lead and manage pharmacologytoxicology studies, including model selection, implementation, and interpretation.Prepare technical documents such as study reports, safety assessments, and regulatory summaries.Ensure pharmacology and safety assessments meet FDA, EMA, and ICH standards.Work with Bioanalytical and Clinical teams to align biomarkers for non-clinical to clinical translation.Conduct risk assessments and advise on safe doses for clinical trials.Collaborate with Research, Early Development, and Clinical teams to implement safety strategies.Partner with non-clinical operations to evaluate and monitor CROs for outsourced studies.Prepare and review publications, presentations, and materials for conferences and journals.Present findings to senior management, regulatory bodies, and external partners.Stay updated on toxicology literature, safety trends, and regulatory guidelines.We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:Ph.D. or equivalent in Toxicology, Pharmacology, or related field (or Master's with significant relevant experience).10+ years in industrial pharmacologytoxicology and drug development.Experience writing non-clinical summaries for regulatory submissions (IND, BLA, etc.), with knowledge of FDA and international guidelines.Strong technical writing, including regulatory submissions, reports, and publications.Expertise in toxicology study designs, safety assessments, and regulatory guidelines.Skilled in analyzing pharmacological, toxicological, and translational data.Excellent communication, organizational, and project management skills.Experience coordinating and documenting nonclinical studies.Gene therapy experience (AAVs or viral vectors) a plus.Proficient in MS Office, document management systems (Veeva, Documentum, Oracle).Knowledge of FDAOECD Good Laboratory Practices.Ability to lead projects and collaborate effectively within teams.Willing to travel to CROs for study monitoring.Why should you apply?By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to bring to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more! In addition, professional development is important to us. By joining our team, you'll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.

Created: 2025-02-22