Non-Clinical & Toxicology Manager M/W
Adocia
Lyon, France
il y a 12j

Job presentation : ADOCIA is recruiting :

Non- Clinical and Toxicology Manager M / W

Within a multidisciplinary team of more than 130 people, you will participate actively in product development in conjunction with other functions of Research and Development.

Key responsibilities :

  • Define and support the non-clinical strategy (pharmacology and toxicology) to enable entry into the clinical development up to commercialization,
  • Manage a small team of non-clinical scientists who oversee the outsourcing of all pharmacology and toxicology studies,
  • Optimize testing strategies after analysis of existing data and utilization of predictive models,
  • Manage and work with CRO's to out-source all in vivo studies (both exploratory and regulatory), working to time and cost,
  • Ensure the delivery of regulatory and clinical documents, eg IMPD, IND, IB for submission to the relevant Health Authorities,
  • Participate in the strategy for the interactions with the regulatory agencies FDA and EMA,
  • Manage the non-clinical aspect of due diligences of potential licenses and of potential partners,
  • Work in a project environment, working closely with scientific management and project management in both early and late developments,
  • Maintain knowledge of regulatory guidelines and scientific trends in the field of non-clinical studies.
  • Profile : You should possess the following :

  • PhD in Toxicology, Pharmacology, or a related discipline,
  • At least 10 years of experience, acquired in the industry in pharmacology and / or toxicology,
  • Good Knowledge of the regulatory guidelines including ICH, GLP
  • Experience of regulatory interactions with FDA and EMA,
  • Capacity to manage and motivate teams,
  • Inter-personal and effective team work skills,
  • Proficiency in English, written and spoken.
  • Driven by Science and Innovation, you are inquisitive and enjoy problem solving. You are creative, optimistic and enjoy working in a team environment.

    You're enjoy working in a highly-paced and ambitious industrial environment

    Adocia promotes excellence in order to bring the best drugs to the patients and to become a valuable partner to large pharmaceutical corporations.

    Please send your application to the attention of :

    Géraldine FAVRE SOULA , Director of Human Resources Development ADOCIA Apply Back to offers

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