Senior Toxicology Scientist - Cell & Gene Therapy

BioSpace; New Jersey; On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

PTO & holidays

Job summary

Legend Biotech, based in Somerset, NJ or Philadelphia, PA, seeks a Sr. Scientist, Toxicology to lead nonclinical safety strategies across cell and gene therapy programs. You will contribute from discovery to IND-enabling development and support regulatory submissions.

The role requires deep toxicology/pharmacology expertise, GLP knowledge, and cross-functional collaboration to advance development while ensuring regulatory compliance and high scientific standards.

Qualifications

• Support nonclinical toxicology and pharmacology for cell and gene therapy programs.
• Contribute to nonclinical strategy from discovery through IND-enabling development.
• Assist in preparation of regulatory submissions and briefing packages.
• Collaborate with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
• Stay current with advances in toxicology and cell/gene therapy development.

Responsibilities

• Design, monitor, and interpret nonclinical safety, pharmacology, biodistribution, and PK studies.
• Support integrated interpretation of toxicology and pharmacology data for candidate selection and risk assessment.
• Contribute to CRO study oversight, including protocol review and data interpretation.
• Prepare responses to health authority questions and investigator brochures as needed.
• Communicate key findings clearly to internal stakeholders and cross-functional teams.

Skills

Nonclinical toxicology

Pharmacology

Regulatory understanding

Scientific writing

Cross-functional collaboration

Education

PhD, DVM, PharmD or equivalent

Tools

GLP studies

Job description

Legend Biotech, based in Somerset, NJ or Philadelphia, PA, seeks a Sr. Scientist, Toxicology to lead nonclinical safety strategies across cell and gene therapy programs. You will contribute from discovery to IND-enabling development and support regulatory submissions.

The role requires deep toxicology/pharmacology expertise, GLP knowledge, and cross-functional collaboration to advance development while ensuring regulatory compliance and high scientific standards.