For our client, a biopharmaceutical company localized in Switzerland, we are looking for a:
Permanent position - 100%
- 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
- 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