Functions and responsibilities
1. Responsible for toxicology activities in Project Teams ensuring that are completed with high quality standards and within approved budgets and timelines.
2. Guidance and management of non-GLP and GLP toxicology activities:
- Preclinical Safety Assessment representative in Project Teams
- Responsible for the management of outsourced studies (budget, quality, timelines, etc.)
- Contribution to Project Teams strategy and execution plans
- Contribution to the interpretation and overall risk assessment of compounds in discovery, reformulation/repositioning and development
- Provide technical input to the regulatory process and interaction with international Regulatory Agencies
3. Ensure that Pharmacokinetics and Drug Metabolism are fully integrated in the activities of safety assessment.
4. To provide advice to Pharmaceutical, Clinical and Regulatory Affairs departments, as well as to other business divisions of the company, to support the safety/risk assessment of products in development or marketed product.
5. Toxicology support to the industrial area (toxicology, occupational risks, ecotoxicology, etc.).
6. Support Business Development in- and out-licensing activities.
Bachelor degree in Pharmacy or related life sciences.
PhD in toxicology or related discipline
In depth knowledge of the pharmaceutical industry with at least 5 years of experience in drug development or as study monitor in toxicology CROs
Specific knowledge and skills
High level of English, essential.
Science-driven, independent worker with the ability to adjust well in a changing environment
Pro-active, solution-oriented and performance-driven
Capability to build and maintain networks
Proven ability of working in complex multi-disciplinary settings