Lead Regulatory Toxicologist, Gene Therapy Safety

F. Hoffmann-La Roche AG; Pennsylvania; Presencial; USD 150.000 - 195.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation benefits

Discretionary annual bonus

Descripción de la vacante

Roche is seeking a Regulatory/Project Toxicologist within our Department of Pharmacology and Toxicology to lead the nonclinical safety for our genetic medicine portfolio, focusing on ocular- and CNS-directed programs from discovery through late-stage development.

You will partner with researchers, clinical, regulatory, CMC, and CROs to design studies, author safety documentation, and drive regulatory milestones while communicating risk assessments to governance committees and health authorities.

Formación

• Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline.
• Minimum 2–3 years of relevant toxicology experience in biopharma, biotech, or CRO.
• Experience designing, executing, and interpreting nonclinical safety studies (GLP and non-GLP).

Responsabilidades

• Lead nonclinical safety strategy for Roche genetic medicine portfolio.
• Design and direct integrated nonclinical safety and toxicology programs.
• Coordinate study execution with CROs and internal teams; review protocols and data.
• Author regulatory submissions and clinical documents; communicate risks to governance.

Conocimientos

Cross-functional leadership

GLP/non-GLP safety studies

Scientific communication

Educación

Ph.D. in Toxicology or Pharmacology

Descripción del empleo

Roche is seeking a Regulatory/Project Toxicologist within our Department of Pharmacology and Toxicology to lead the nonclinical safety for our genetic medicine portfolio, focusing on ocular- and CNS-directed programs from discovery through late-stage development.

You will partner with researchers, clinical, regulatory, CMC, and CROs to design studies, author safety documentation, and drive regulatory milestones while communicating risk assessments to governance committees and health authorities.