Toxicology Expert

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We are looking for an experienced toxicology expert to join our Montpellier, France facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.

As the toxicology expert you will contribute to the development of life-transforming drugs by supporting multiple programs in drug development

Responsibilities 

Responsible for all non-clinical and clinical toxicology studies:

  • Design and lead all toxicology studies (in-vivo/ex-vivo/in-vitro non-GLP exploratory, GLP-compliant regulatory Toxicology studies, including Toxicokinetics)
  • Address and communicate efficiently on all complex toxicological and biological issues related to the study outcome
  • Author and assess toxicology related technical documents

Serve as main point of contact for toxicology subject matters and represent MedinCell in external scientific meetings and with potential partners

Work alongside multi-discliplinary project teams to track toxicology activities against approved timelines and milestones, and ensure adherence to agreed-upon objectives and deliverables

Assist the regulatory team with writing and/or supporting regulatory submissions relating to toxicology

Requirements

Experience in non-clinical toxicology assessment with 4-6 years of experience within pharmaceutical industry and with a background in Toxicokinetics

Understanding drug development and regulatory processes for small molecules, peptides and biologics

Experience in injectable drug products is highly desirable

Strong knowledge of GLP-compliance and relevant ICH & FDA guidance documents related to safety and TK/PK studies

Experience in non-compartmental toxicokinetic/pharmacokinetic analysis by using an appropriate software (Phoenix®)

Experience in ADME studies would be a plus

Skills and Qualification

PhD in toxicology or a related field

Board certification in Toxicology is highly desirable

Fluency in English

Demonstrated ability to produce high quality written documents that effectively communicate in a clear, organised and concise manner

High degree of autonomy

Experience in international and multidisciplinary teams


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