Project Toxicologist
Core
Lead nonclinical safety strategy for Roche's innovative genetic medicine portfolio, focusing on ocular- and CNS-directed gene therapies from discovery through late-stage clinical development.
Role type
Senior nonclinical safety lead / project toxicologist
Builds
Nonclinical safety strategies and regulatory filings for gene therapy programs
Domain
Biopharmaceuticals / Genetic Medicine / Toxicology
Required skills
Nonclinical safety strategy design, GLP/non-GLP study execution, regulatory filing authoring, cross-functional leadership, complex data interpretation, risk identification
Preferred skills
Genetic medicine experience, viral vector (AAV) expertise, gene editing platform knowledge, ocular/CNS therapeutic development, health authority interaction
Technologies
GLP, non-GLP, IND, CTA, PIP, BLA, GMO applications, Investigator Brochures, ICFs
Responsibilities
Formulate integrated nonclinical safety strategies, lead proactive safety risk identification, partner with cross-functional teams to coordinate study execution, author regulatory and clinical safety documentation, communicate safety findings to governance committees and health authorities
Seniority
Senior, hands-on IC