Nonclinical Safety Lead, Gene Therapy

F. Hoffmann-La Roche AG; Philadelphia (Philadelphia County); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Roche seeks a Regulatory/Project Toxicologist to lead nonclinical safety strategy for gene-therapy programs from discovery to late-stage development. You will work with multidisciplinary scientists to accelerate safe, patient-ready medicines.

You will serve as the nonclinical safety lead on cross-functional teams, design safety studies, coordinate CROs, and author regulatory documents, communicating findings to governance and health authorities.

Qualifications

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• 2–3 years of experience in toxicology within biopharma, biotech, or CROs.
• Experience designing and interpreting nonclinical safety studies (GLP and non-GLP).
• Understanding of drug development and the role of nonclinical safety in regulatory and early clinical strategy.
• Excellent communication and cross-functional leadership skills.

Responsibilities

• Serve as the nonclinical safety lead on cross-functional drug development teams.
• Design, implement, and interpret integrated nonclinical safety strategies (GLP and non-GLP).
• Coordinate study execution with CROs and internal leads; review protocols.
• Author and review nonclinical safety documentation and regulatory submissions.
• Communicate findings and risk assessments to governance and health authorities.

Skills

Nonclinical safety design

GLP studies

Toxicology data interpretation

Cross-functional collaboration

Regulatory documentation

Education

Ph.D. in Toxicology or Pharmacology

Job description

Roche seeks a Regulatory/Project Toxicologist to lead nonclinical safety strategy for gene-therapy programs from discovery to late-stage development. You will work with multidisciplinary scientists to accelerate safe, patient-ready medicines.

You will serve as the nonclinical safety lead on cross-functional teams, design safety studies, coordinate CROs, and author regulatory documents, communicating findings to governance and health authorities.