Group Leader Toxicology/ Preclinical Safety

Posted 4 months ago

Key responsibilities

  • Responsible for the overall toxicology/preclinical safety strategy for assigned projects (small molecules & biologics)
  • Lead and manage a team of 2-3 preclinical toxicologists
  • Responsible for preclinical safety evaluation of in-licensing opportunities and early compound selection
  • Act as Toxicology Subject Matter Expert (SME) for multidisciplinary teams and senior management
  • Identify, select and oversee preclinical safety studies at Contract Research Organizations
  • Responsible for the yearly functional budget & resources allocation, and to ensure the quality of tox programs executed on time and within budgets
  • Responsible for the preparation and review of preclinical safety regulatory documents (including IDB, summaries for IND and IMPD, briefing documentation)
  • Drive mechanistic studies on toxicology findings and identification of early safety biomarkers
  • Work in a matrix organization in close collaboration with other Translational Medicine functions, reporting to the Head of TranslationalMedicine
  • Present to internal and external scientific communities & congresses

Your profile

  • University degree in Life Science (Ph.D. in relevant expertise area or equivalent in biomedicine)
  • Min. 8-10 years demonstrated experience in Toxicology/Preclinical Safety across various stages of drug development
  • Experience in the pharma industry in designing and overseeing nonclinical toxicology studies to support clinical development and regulatory submissions is a must
  • Experience in interactions with regulatory authorities and preparation of regulatory documentation
  • Demonstrated ability to manage multiple projects across various development stages. Experience in Oncology is an asset
  • Knowledge in preclinical research, GCLP, ICH guidelines, and animal welfare regulations
  • Previous lead and management experience is an asset
  • Scientific rigor & interest, curiosity, analytical and organizational skills
  • Broad understanding of, and experience in contributing to Translational Medicine roadmap
  • Excellent communication and presentation skills (oral and written)
  • Accustomed to working in a matrix organization with timelines-driven projects
  • Fluent in English

Job Features


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