Principal Scientist - Toxicology

Role Summary

Principal Scientist in Toxicology to pioneer Novo Nordisk's strategy for small molecule early safety assessment. Requires deep subject matter expertise in exploratory toxicology for small molecules and an entrepreneurial mindset to work in a growing small molecule pipeline. You will collaborate with experienced colleagues in exploratory and computational toxicology to evaluate early safety data (in vitro/in vivo) to support lead optimization and lead candidate selection, and guide, manage, and interpret toxicity data performed at contract research organizations in close collaboration with project scientists and leadership.

You will be part of a subject matter expert team developing Novo Nordisk's strategy for early investigative/exploratory toxicology and communicating evaluations across the small molecule pipeline.

• Initiating, monitoring and reporting Exploratory Toxicology studies/data
  • Supervise the execution of in silico, in vitro and in vivo toxicology studies at CROs/technology providers to assess safety profiles and progress chemical leads.
  • Identify and secure optimal exploratory toxicology screening plans in alignment with a cross-functional team including chemists, biologists, and ADME scientists to secure a customized lead optimization process (design, make, test, analyze).
  • Analyze, interpret and contextualize data to inform safety assessments and decision-making.
• Lead, support, and develop the Small Molecule Exploratory Toxicology Strategy Implementation in close collaboration with global colleagues
  • Follow the development of the field of exploratory toxicology at industry peers, CROs and technology providers.
  • Ensure alignment with relevant industry standards, GxP requirements and regulatory standards.
  • Collaborate with cross-functional teams to integrate Exploratory Toxicology strategies into broader drug discovery and development plans.
• Support Due Diligence (DD) processes
• Assess potential assets based on available safety related information and drug-ability and advise decision making based on data and possible follow-up strategies in collaboration with global DD teams
• Advisory and Mentorship
  • Provide expert advisory functions on Exploratory Toxicology/non-clinical safety matters to relevant colleagues and stakeholders
  • Mentor and guide colleagues in developing their expertise in Exploratory Toxicology/non-clinical safety
  • Problem Solving and Innovation
    • Identify and solve complex safety-related challenges using a broad drug discovery and drug development perspective
    • Recommend innovative solutions and best practices to improve the Exploratory Toxicology/safety evaluation processes
    • Stay abreast of industry trends and advancements to maintain cutting-edge expertise

• Master’s degree with 12+ years of relevant experience, or PhD with 8+ years of relevant experience required.
• Proven industry expertise in small molecule exploratory toxicology, successfully delivering industry standard clinical candidates based on cross discipline lead optimization.
• Medicinal chemistry subject matter expertise is key to assess inherent molecular toxicity risks and to foster close discussion with project chemists
• Strong background with in vitro assays and in silico analysis is advantageous
• Experience with predictive toxicity SAR tools (e.g. DEREK) is an advantage
• Experience working with cross functional teams and proven ability to communicate findings/results to non-SMEs.
• Solves complex safety problems with a broad perspective, identifying innovative solutions to promote project progression.
• Assess, evaluate and implement new in vitro and in vivo methods relevant for non-clinical safety evaluation/prediction.
• Communicates evaluations and implications of non-clinical safety findings effectively.
• Acts as a mentor for colleagues, fostering expertise within the organization.
• Experience in regulatory toxicology and understanding of ICH guidelines is advantageous.