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上海市, 中国
Onsite
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Position:
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 and due diligence activities across all therapeutic areas.
This individual will provide strategic guidance for China-specific development, regulatory interactions, and safety assessment while ensuring alignment with global development strategies. The role requires deep expertise in toxicology, nonclinical safety and PK study design and execution, compliance with international guidelines, CRO study oversight and China's evolving regulatory landscape, combined with the ability to influence across functions, organizations, and geographic regions.
Scope of the position:
The Principal/Senior Principal Toxicologist will:
Serve as the China subject matter expert (SME) for translational safety and China regulatory requirements supporting China development programs in collaboration with gRED Translational Safety colleagues.
Partner closely with gRED project toxicologists to optimize safety strategies for China development, registration and lifecycle management.
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 Contract Research Organizations (CROs) in China and other countries in Asia.
Will serve as the Translational Safety lead for Asia Partnering and participate in due diligence activities with potential China partners.
Represent Translational Safety on China governance committees and cross-functional development teams as needed.
Drive scientific excellence by incorporating innovative approaches, including Weight of Evidence (WoE) and New Approach Methodologies (NAMs), into nonclincial safety assessment.
Responsibilities:
Leads the nonclinical safety assessment of Genentech Research and Early Development (gRED) therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity, strategic planning, and designing/implementing/supervising toxicology studies in support of program advancement.
Scientific leadership in the design and implementation of translational safety strategies to support program advancement and decision-making.
Investigate mechanisms of toxicity.
Proactive management of potential safety liabilities and communication of impact to teams and governance committees.
Closely collaborate with pathologists, study operations professionals, pharmacokineticists, and pharmaceutics to create streamlined, innovative translation safety programs for Genentech drug candidates; and to author regulatory documents.
Closely collaborate with predictive toxicologists to incorporate NAM approaches (e.g. in silico, in vitro models) into safety strategies.
Work independently to leverage literature to develop and optimize best-evidence arguments in support of data interpretation or experimental approaches.
Partner with the colleagues in China Innovation center of Roche (CiCOR) on nonclinical safety strategies, regulatory interactions, and CRO oversight
Provide onsite technical oversight of the toxicology studies conducted at CROs.
Conduct due diligence reviews of potential partnering programs.
Participate in and lead interdisciplinary project teams.
Represent Genentech/Roche in meetings with regulatory authorities as needed.
Provide functional area mentorship and leadership within Translational Safety.
Qualification and Experience:
Ph.D. in Toxicology or a related life sciences discipline, with postdoctoral training or equivalent research experience, and a minimum of 8 years of relevant experience in the pharmaceutical, biotechnology, or CRO industry supporting nonclinical safety and translational toxicology across drug discovery and development.
Demonstrated expertise in the design, scientific oversight, and interpretation of a broad range of exploratory and GLP nonclinical toxicology studies. Knowledge of emerging NAM approaches is preferred
Extensive experience managing outsourced toxicology programs and CRO partnerships to ensure high-quality study execution, regulatory compliance, and timely delivery.
Proven experience supporting drug discovery and development programs, including the development of nonclinical safety strategies and regulatory submissions. Experienced with China regulatory requirements and interactions with NMPA/CDE.
A demonstrated track record of scientific impact, evidenced by significant contributions to project advancement, regulatory success, and influence both within the organization and the broader scientific community.
Strong decision-making, complex problem-solving, critical data analysis, and benefit–risk assessment
Proven ability to lead and influence cross-functional teams in a highly matrixed global environment, build productive collaborations across disciplines and regions, and effectively communicate complex scientific concepts to project teams, governance committees, senior leadership, and regulatory agencies.
Be fluent in both English and Mandarin, with excellent written and verbal communication skills.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
