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