Principal Toxicologist

Position:
Principal/Senior Principal Scientist - Toxicology

Company:
Roche

Location:
China, Shanghai

Employment type:
Full time

Short Summary:
We are seeking a highly motivated and experienced Principal/Senior Principal Toxicologist to provide translational safety leadership for Genentech's growing China development portfolio. The successful candidate will serve as the China Translational Safety scientific and regulatory lead, partnering closely with gRED Translational Safety colleagues and cross-functional teams to support drug discovery and development efforts.

Responsibilities:
- Serve as the China subject matter expert (SME) for translational safety and China regulatory requirements.
- Partner closely with gRED project toxicologists to optimize safety strategies for China development.
- Build productive scientific relationships with China regulatory authorities (e.g., NMPA/CDE) and CRO partners.
- Provide onsite technical oversight of the toxicology studies conducted at CROs.
- Drive scientific excellence by incorporating innovative approaches into nonclinical safety assessment.
- Lead the nonclinical safety assessment of Genentech Research and Early Development (gRED) therapeutics.
- Investigate mechanisms of toxicity and manage potential safety liabilities.
- Collaborate with pathologists, study operations professionals, and pharmacokineticists.
- Conduct due diligence reviews of potential partnering programs.
- Represent Genentech/Roche in meetings with regulatory authorities as needed.

Requirement:
- Ph.D. in Toxicology or a related life sciences discipline with a minimum of 8 years of relevant experience.
- Demonstrated expertise in the design and oversight of nonclinical toxicology studies.
- Extensive experience managing outsourced toxicology programs and CRO partnerships.
- Proven experience supporting drug discovery and development programs.
- Experienced with China regulatory requirements and interactions with NMPA/CDE.
- Strong decision-making, problem-solving, and critical data analysis skills.
- Fluent in both English and Mandarin, with excellent communication skills.

Benefits:
- Join a global team dedicated to advancing science and ensuring access to healthcare.
- Opportunities for personal expression and professional growth.
- Work in a culture that values diversity and collaboration.