Sr. Scientist, Toxicology

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 independently while thriving in a collaborative, matrixed team environment.
• #Li-JR1
• #Li-Hybrid
• Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits

Additional Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of 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.

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