About This Role
This role involves spearheading the nonclinical safety strategy for Roche's innovative genetic medicine portfolio. The Project Toxicologist champions the safety evaluation of cutting-edge gene therapies, focusing on ocular- and CNS-directed programs from early discovery through late-stage clinical development. This position collaborates with multidisciplinary scientists to drive decisions that safely accelerate groundbreaking medicines to patients.
Responsibilities
- Serve as the nonclinical safety lead and primary toxicology representative on cross-functional drug development project teams across discovery, pre-clinical, and clinical stages
- Formulate, design, and direct integrated nonclinical safety and toxicology strategies (GLP and non-GLP) to support program progression and key regulatory milestones
- Lead proactive safety risk identification and design investigative mechanistic studies to evaluate and mitigate treatment-related toxicities
- Partner cross-functionally with Research Leads, Clinical, Regulatory, CMC, and external CROs to coordinate study execution, review protocols, and interpret complex safety data
- Author and review comprehensive nonclinical safety documentation, high-level regulatory filings (e.g., INDs, CTAs, PIPs, BLAs, GMO applications), and clinical documents (Investigator Brochures, ICFs)
- Communicate scientific findings and safety risk assessments clearly to internal governance committees and represent the organization in meetings with global health authorities
Requirements
- Ph.D. in Toxicology, Pharmacology, or a closely related scientific discipline
- Minimum of 2–3 years of relevant toxicology experience within the biopharmaceutical, biotechnology, or contract research (CRO) industry
- Demonstrated experience in designing, executing, and interpreting robust nonclinical safety studies (GLP and non-GLP) that drive scientific and portfolio decisions
- Working understanding of drug development processes and the role of nonclinical safety in guiding regulatory and early clinical strategies
- Exceptional communicator and collaborator, recognized for critical data interpretation, complex scientific problem-solving, and cross-functional leadership
Nice to have:
- Direct experience with genetic medicines, viral vectors (particularly AAVs), gene editing platforms, or novel RNA/oligonucleotide modalities
- Prior experience with ocular- or central nervous system (CNS)-targeted drug delivery or therapeutic development
- Demonstrated track record of authoring nonclinical regulatory modules for global health authority dossiers (IND/CTA) and participating in health authority interactions
- Proven ability to manage multiple complex safety programs simultaneously while driving collaborative relationships with CRO partners and academic collaborators
