Sr. Scientist, Toxicology

Role: Senior Scientist, Toxicology supporting nonclinical safety assessments for cell and gene therapy programs across discovery to IND-enabling stages. Responsibilities: design, monitor, interpret, and report toxicology, pharmacology, biodistribution, and pharmacokinetics studies; contribute to study strategy, CRO oversight, and regulatory documentation; support safety risk assessments for advanced therapies; collaborate with multidisciplinary teams including Pharmacology, CMC, Clinical, and Regulatory Affairs; stay current with scientific and regulatory developments. Requirements: Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, or related fields; at least 5 years in nonclinical toxicology within biotech or pharma, with experience in cell/gene therapies preferred; knowledge of GLP toxicology, CRO management, and regulatory standards (FDA, EMA, ICH); strong scientific communication skills and ability to work independently in a team. High-Value: cell and gene therapy, biologics, IND-stage, nonclinical safety, regulatory submissions, GLP compliance, cross-functional collaboration. Work setup: based in Somerset, NJ or Philadelphia, PA, with the need for potential collaboration across teams and external CROs.