Principal / Senior Principal Scientist - Toxicology

About the role

Roche is seeking a Principal / Senior Principal Toxicologist to provide translational safety leadership for Genentech's growing China development portfolio. The successful candidate will act as the China Translational Safety scientific and regulatory lead, working with gRED Translational Safety colleagues and cross-functional teams to support drug discovery, development and due diligence across all therapeutic areas, while guiding China-specific regulatory interactions and safety assessments in line with global strategy.

Key responsibilities

• Serve as the China subject matter expert for translational safety and regulatory requirements, partnering with gRED project toxicologists to optimise safety strategies for registration and lifecycle management.
• Build scientific relationships with China regulatory authorities (NMPA/CDE) and CRO partners, and provide onsite technical oversight of toxicology studies at CROs in China and other Asian countries.
• Lead the nonclinical safety assessment of gRED therapeutics, including designing and supervising toxicology studies, investigating mechanisms of toxicity and managing potential safety liabilities.
• Incorporate Weight of Evidence (WoE) and New Approach Methodologies (NAMs) into safety assessment, and work with pathologists, pharmacokineticists and predictive toxicologists.
• Take part in due diligence with potential China partners, represent Translational Safety on governance committees, and lead interdisciplinary project teams.
• Represent Genentech/Roche in meetings with regulatory authorities and provide mentorship and leadership within Translational Safety.

Required profile

• Ph.D. in Toxicology or a related life sciences discipline, with postdoctoral training or equivalent research experience.
• Minimum 8 years of relevant experience in the pharmaceutical, biotechnology or CRO industry supporting nonclinical safety and translational toxicology.
• Extensive experience managing outsourced toxicology programs and CRO partnerships, and proven experience with China regulatory requirements and NMPA/CDE interactions.
• Fluent in both English and Mandarin, with excellent written and verbal communication skills.

Required skills

• Design, scientific oversight and interpretation of exploratory and GLP nonclinical toxicology studies.
• Knowledge of emerging NAM approaches is preferred.
• Strong decision-making, complex problem-solving, critical data analysis and benefit-risk assessment.
• Ability to lead and influence cross-functional teams in a matrixed global environment.