Sr. Scientist, Toxicology
Legend Biotech
August 20, 2026
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Role Overview
Sr. Scientist, Toxicology to support nonclinical development and safety assessment across cell and gene therapy programs. Contribute to nonclinical strategy from discovery through IND-enabling development and support regulatory submissions.
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.
- Integrate toxicology and pharmacology data for candidate selection, risk assessment, and program progression.
- Contribute to CRO study strategy and execution (protocol review, monitoring, data interpretation, final report review).
- Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
- Prepare regulatory documents (briefing packages, pre-IND/IND submissions, investigator brochures, and responses to health authority questions).
- Perform safety risk assessments (target biology, exaggerated pharmacology, off-target effects, immunogenicity, genome-related risks, long-term safety).
- Interpret nonclinical datasets and clearly communicate findings/recommendations.
- Stay current on scientific/regulatory advances relevant to toxicology and cell/gene therapy.
- Support in vivo pharmacology activities as needed (efficacy, disposition, safety).
Requirements
- Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, Immunology, or related field.
- 5+ years nonclinical toxicology (or related) in biotech/pharma R&D; working knowledge of pharmacology principles.
- GLP toxicology and nonclinical pharmacology experience; CRO management; nonclinical regulatory expectations.
- Understanding of FDA, EMA, and ICH regulations for toxicology and cell/gene therapy.
- Scientific writing, communication, presentation; independent yet collaborative.
Preferred
- Experience with cell/gene therapy, biologics, or advanced therapeutic platforms.
- Experience with IND/CTA-enabling packages and global regulatory submissions.
Benefits (full-time permanent employees)
- Medical/dental/vision; 401(k) match (fully vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays) and 11 company holidays; plus other voluntary benefits.
Work Authorization
- Must be authorized to work in the United States (E-Verify; Form I-9 required if selected).
Sr. Scientist, Toxicology to support nonclinical development and safety assessment across cell and gene therapy programs. Contribute to nonclinical strategy from discovery through IND-enabling development and support regulatory submissions.
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.
- Integrate toxicology and pharmacology data for candidate selection, risk assessment, and program progression.
- Contribute to CRO study strategy and execution (protocol review, monitoring, data interpretation, final report review).
- Partner with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
- Prepare regulatory documents (briefing packages, pre-IND/IND submissions, investigator brochures, and responses to health authority questions).
- Perform safety risk assessments (target biology, exaggerated pharmacology, off-target effects, immunogenicity, genome-related risks, long-term safety).
- Interpret nonclinical datasets and clearly communicate findings/recommendations.
- Stay current on scientific/regulatory advances relevant to toxicology and cell/gene therapy.
- Support in vivo pharmacology activities as needed (efficacy, disposition, safety).
Requirements
- Ph.D., DVM, PharmD, or equivalent in Toxicology, Pharmacology, Immunology, or related field.
- 5+ years nonclinical toxicology (or related) in biotech/pharma R&D; working knowledge of pharmacology principles.
- GLP toxicology and nonclinical pharmacology experience; CRO management; nonclinical regulatory expectations.
- Understanding of FDA, EMA, and ICH regulations for toxicology and cell/gene therapy.
- Scientific writing, communication, presentation; independent yet collaborative.
Preferred
- Experience with cell/gene therapy, biologics, or advanced therapeutic platforms.
- Experience with IND/CTA-enabling packages and global regulatory submissions.
Benefits (full-time permanent employees)
- Medical/dental/vision; 401(k) match (fully vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays) and 11 company holidays; plus other voluntary benefits.
Work Authorization
- Must be authorized to work in the United States (E-Verify; Form I-9 required if selected).