Sr. Scientist, Toxicology

Legend Biotech USA; Philadelphia (Philadelphia County); On-site; USD 90,000 - 120,000; Full time

Job summary

Legend Biotech USA is looking for a Sr. Scientist in Toxicology to join their Early Drug Development team based in Somerset, NJ or Philadelphia, PA. This role will contribute to nonclinical strategy and safety assessment for cell and gene therapy programs.

The ideal candidate will possess a Ph.D. or equivalent, with a minimum of 5 years' experience in nonclinical toxicology. The position demands scientific expertise, strong communication abilities, and the capacity to work collaboratively within fast-paced teams.

Benefits are available exclusively to permanent full-time employees.

Qualifications

• Minimum of 5 years of experience in nonclinical toxicology or related field within biotech or pharma.
• Experience supporting cell therapy, gene therapy, or biologics preferred.
• Understanding of FDA, EMA, and ICH regulations regarding toxicology.

Responsibilities

• Support toxicology activities for cell and gene therapy programs.
• Design, monitor, and interpret nonclinical safety studies.
• Contribute to regulatory submissions and safety risk assessments.

Skills

Scientific writing

Communication skills

Presentation skills

Regulatory knowledge

Pharmacology principles

Education

Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, Immunology

Job description

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.

These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.

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.

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