Director, Preclinical Safety (Toxicology) China Head

About the role

Novartis is looking for a Director, Preclinical Safety (Toxicology) China Head based in Shanghai. The role leads the preclinical safety function in China, working with multi-disciplinary teams during due diligence to assess nonclinical safety programs for external drug candidates and giving line-function aligned recommendations on follow-up actions.

Key responsibilities

• Carry out due diligence under compressed timelines, quickly identifying key issues and communicating risks, gaps and conclusions clearly to the due diligence team
• Lead cross-disciplinary teams to evaluate potential nonclinical safety issues or findings
• Work with the PCS TA Head and the Global Head of PCS so that safety assessments, mitigation strategies and development plans are aligned
• Collaborate with the Translational Medicine External Program (TEP) team to implement the TEP model and improve processes
• Support Biomedical Research Integration Office (BRIO) integration activities
• Act as a mentor and role model for talent development, coaching and performance discussions
• Author the nonclinical safety sections of due diligence reports, including risks, issues, gaps and mitigation strategies
• Provide PCS development strategy and resourcing needs in the clinical development plan
• Contribute to the handover package specifying vendor requirements for transferring PCS methodologies, data, samples and reports after deal signature, and work with BRIO on a smooth handover to the PCS project team
• Maintain strict confidentiality and legal compliance, and mentor colleagues on drug development strategy

Required profile

• PhD in pharmacology, toxicology or a related biological science; or DVM, PharmD, M.S. or equivalent with appropriate training, a strong biological background or equivalent experience
• At least 8 years of full-time experience as a nonclinical safety expert in the pharmaceutical industry
• Fluent English and excellent oral and written communication
• Ability to anticipate and analyse issues independently and to manage multiple projects at once
• Scientific and regulatory expertise in drug development and safety assessment, and familiarity with R&D disciplines beyond nonclinical safety
• Broad knowledge of regulatory guidelines, quality management processes and animal welfare requirements

Required skills

• Animal models and toxicology
• Bioinformatics and data analysis
• Regulatory compliance and risk assessment
• Leadership, management and mentorship