Type of placement:
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Senior Project Toxicologist for a permanent position based in the Basel area.
The ideal candidate should have at least six years of previous experience as a project toxicologist.
- Arrange and authorise integrative assessments of the non-clinical safety in regulatory documents (e.g. for IB, IND, IMPD, CTA, CTD, DSURs PSURs, briefing books);
- Represent the toxicology department in research and development project teams and in interactions with competent authorities (e.g. National Health Authorities, FDA, CHMP);
- Develop overall non-clinical safety strategies in conjunction with other research and development functions;
- Design and direct in-house pilot toxicity studies in rodents;
- Interpret study results and report in an appropriate form (e.g. research reports, publications, presentations);
- Design and monitor toxicity and safety pharmacology studies performed at CROs;
- Respond to information requests from national and international agencies related to non-clinical safety studies;
- Prepare toxicological expert statements for impurities and excipients, cleaning validation, worker's safety,
- Maintain state of the art expert scientific, technical and regulatory knowledge in the area of toxicology and safety pharmacology;
- Liaise with key consultants and scientists in the field.
Qualifications and Experience:
- A University Degree in toxicology, pharmacy, human medicine, veterinary medicine, biochemistry, biology or any other natural science is required;
- Strong knowledge of the regulatory environment regarding preclinical development of new drugs to support clinical development of all phases;
- Experience in authoring / reviewing of preclinical safety parts of regulatory documents (e.g. IB, IND, briefing books, NDA / MAA submission documents);
- Experience in communicating with Health Authorities;
- Additional qualification as expert in toxicology (e.g. ERT) is desirable;
- Knowledge about SEND compliant documentation is desirable;
- Excellent command of English, both oral and written;
- Ability to communicate effectively with a wide range of internal and external stakeholders;
- Motivated and reliable personality and a committed team player;
- Relevant working/residency permit or Swiss/EU-Citizenship required.