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Principal Toxicologist - Permanent position (BB-8CEF6)

Gefunden in: Neuvoo CH

Beschreibung:

For our client, a biopharmaceutical company localized in Switzerland, we are looking for a:

Principal toxicologist

Permanent position - 100%

RESPONSIBILITIES

  • Set the overall strategy for toxicology programs for various projects
  • Design, implement and manage toxicology and non-clinical safety pharmacology studies
  • Supervise the analysis and data interpretation of in vitro safety studies
  • Recommend and manage selected CRO relationships including the coordination of outsourced studies to ensure accurately reporting of results, compliance with study protocol and regulatory requirements.
  • Provide interpretation of the data and toxicology guidance to the internal clinical, regulatory and research groups.
  • Take responsibility for the writing of the non-clinical safety and toxicology sections of regulatory documents and interactions with health authorities.
  • Review of scientific literature relevant to preclinical product development.
  • Ensure compliances with GLP regulations in designing protocols, analyzing and interpreting the data and preparing relevant documentation.
  • Support the business development team on technical due diligence associated with out-licensing, and co-development agreements regarding non-clinical safety aspects.
  • Complete activities in a timely manner that allow a project to achieve deliverables and milestones
  • Provide toxicology and non-clinical safety expertise as a project team member
  • PROFILE

  • Ph.D. in Toxicology or Pharmacology or 3-5 years of study director experience in a CRO
  • At least 5-7 years of non-clinical safety experience in the biotechnology or pharmaceutical industry and track record of interacting with regulatory agencies
  • Supervisory experience in the biotechnology or pharmaceutical industry or a respective CRO
  • Current with GLP regulations and experience in writing SOPs and study reports
  • Leadership and project management skills
  • French and English fluent
  • YOUR KELLY CONTACT

    Mrs Charline Maire

    Consultant Professional Staffing Life Science

    Kelly Scientific Geneva

    calendar_todayvor 1 Tag

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