Senior Scientist Toxicology positions focus on delivering results in their domain. This page aggregates open Senior Scientist Toxicology roles and what employers typically expect.
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a Sr. Scientist, Toxicology as part of the Early Drug Development team based in Somerset, NJ or Philadelphia, PA . Role Overview Legend Biotech is seeking a Sr. Scientist, Toxicology to support nonclinical development and safety assessment across cell and gene therapy programs. This individual will contribute to nonclinical strategy from discovery through IND-enabling development and support regulatory submissions for innovative advanced therapies. The role requires scientific expertise in toxicology, a foundation in pharmacology, understanding of regulatory expectations, and the ability to work effectively across cross-functional teams in a fast-paced biotech environment. Key Responsibilities Support toxicology activities for discovery and development-stage cell and gene therapy programs. Design, monitor, interpret, and report nonclinical safety, pharmacology, biodistribution, and pharmacokinetic studies. Support integrated interpretation of toxicology and pharmacology data to enable candidate selection, risk assessment, and program progression. Contribute to study strategy and execution at CROs, including protocol review, study monitoring, data interpretation, and final report review. Partner closely with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams to advance development programs. Support preparation of regulatory documents, including briefing packages, pre-IND/IND submissions, investigator brochures, and responses to health authority questions. Contribute to safety risk assessments related to target biology, exaggerated pharmacology, off-target effects, immunogenicity, genome-related risks, and long-term safety. Interpret complex nonclinical datasets and communicate key findings and recommendations clearly to internal stakeholders. Stay current with scientific and regulatory advances relevant to toxicology, pharmacology, and cell and gene therapy development. Support in vivo pharmacology activities, when needed, through integrated assessment of efficacy, disposition, and safety findings. Requirements Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or a related discipline. Minimum of 5 years of experience in nonclinical toxicology or a related field within biotechnology or pharmaceutical R&D, with working knowledge of pharmacology principles. Experience supporting cell therapy, gene therapy, biologics, or other advanced therapeutic platforms preferred. Working knowledge of GLP toxicology studies, nonclinical pharmacology studies, CRO management, and regulatory expectations for nonclinical development. Experience contributing to IND/CTA-enabling packages and global regulatory submissions is highly desirable. Understanding of FDA, EMA, and ICH regulations pertaining to toxicology and cell and gene therapy development. Scientific writing, communication, and presentation skills. Ability to work…