Sr. Scientist, Toxicology

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.

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 independently while thriving in a collaborative matrixed team environment.

#Li-JR1

#Li-Hybrid

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth related medical conditions and lactation) gender identity or gender expression (including transgender status) sexual orientation marital status military service and veteran status disability genetic information or any other protected characteristic under applicable federal state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.