To support the growing R&D pipeline, there is a need to recruit additional toxicologists to join NCD. In this role, you will be responsible for the delivery of the non-clinical safety assessment component of the drug development plan for projects in research and in clinical development. This will be delivered through the effective management of both internal and external resources.
Key responsibilities
- Developing overall non-clinical drug safety strategies in conjunction with other research and development functions.
- Maintaining expert scientific and technical knowledge in the area of toxicology.
- Liaising with key consultants and scientists in the field.
- Planning resource requirements for the assigned projects.
- Representing Non-Clinical Development in research and development project teams.
- Reports to Head of Non-Clinical Drug Safety.
Main tasks
- Designing and monitoring toxicity studies performed at CROs
- Writing study plans and study reports for in vivo studies (plasma and tissue PK, tolerability and toxicology) based on instructions from Project Leaders under consideration of general practices, own practical skills and in strict compliance with animal welfare legislation.
- Interpreting study results and reporting them in an appropriate form (e.g. research reports, publications, presentations)
- Preparing integrative assessments of the safety of new medicines (e.g. for IND, IDB, CTX, CTD)
Requirements
- PhD in toxicology, biology, in-vivo studies or in a related field, Pharm D or DVM, you will bring to the role considerable knowledge of toxicology, including several years’ experience in the development of biological products.
- You will demonstrate a sound appreciation of pharmacology and immunology, together with an ability to understand disease processes and the pharmacological mechanisms behind toxic effects of pharmaceuticals.
- A solid understanding of the regulatory requirements for the toxicological testing of biological products is highly desirable, as is a successful track record of managing outsourced studies.
- Experience and training in general toxicology.
- At least 3 years of work experience as study director or in toxicological assessments of xenobiotics.
- Continuous education internal as well as external in the field of in vivo studies.
- Education and accreditation to work with in vivo models.
- Recognized expertise in a specific non-clinical safey field would be a plus (e. g. safety pharmacology, immunotoxicity, reproductive and developmental toxicology, clinical pathology or histopathology).
- Good command of English.
- Highly motivated, organized, recognized and reliable personality and a committed team player.
Interested candidates should send their CV, references and a cover letter by email or by regular mail to:
Human Resources
Addex Pharmaceuticals France
Immeuble Alliance
Bâtiment C
74160 Archamps
France
Please quote reference "LH in vivo NCD" when replying.