- Experience Level
- Experienced (non-manager)
Are you looking for your next step within the Pharma industry and open to working independently, in a dynamic setting, where the team knows they are making a significant difference to their patient community?
You will be responsible for planning, overseeing, interpreting and reporting non-clinical Safety and Toxicology Studies for early and late stage studies, with a focus on the generation of regulatory enabling GLP study packages and contributing to regulatory documentation and interactions.
The role involves designing and monitoring the non-clinical safety and toxicology studies conducted internally and externally both in a GLP and non-GLP environment and the interpretation, communication and reporting of non-clinical safety data generated.
Responsibilities of the role:
- Designing, planning, monitoring and interpreting toxicity and safety pharmacology performed at CROs, ensuring presentation of data is accurate and supports the conclusions
- Preparing and authoring integrative assessments of the non-clinical safety in regulatory documents (e.g. for IB, IND, IMPD, CTA, CTD, DSURs PSURs, briefing books)
- Providing responses to information requests from national and international agencies related to non-clinical safety studies
- Identification of threats to the pre-clinical safety assessment plan, proposing options for resolution or mitigation of these threats, ensuring the implementation of appropriate adjustments to the toxicology strategy. Actively integrating multidisciplinary research and development project teams
- Maintaining expert scientific, technical and regulatory knowledge in toxicology and safety pharmacology, liaising with key consultants and scientists in the field
- Interacting with competent authorities (e.g. FDA, EMA, CHMP), collaborations, partnership discussions, conferences, and scientific advisory board
- PhD-level toxicology, pharmacology, veterinary medicine
- Minimum 7 years’ experience in similar positions in the Biotech/Pharmaceutical industry
- Proven expertise in management and leadership of multiple parallel programs in a matrix organization
- Strong knowledge on the drug development process and of the regulatory environment regarding preclinical development of new drugs to support clinical development of all phases. Solid understanding of all GLP guidelines
- Experience in authoring / reviewing of preclinical safety parts of regulatory documents (e.g. IB, IND, briefing books, NDA / MAA submission documents)
- Understanding of the CRO’s function
- Excellent understanding of pharmacological and toxicological mechanisms as the basis of developing safe medicines
- Track record on supporting the development of clinical candidates
Salary: €70,000 - €95,000 Per annum Plus Benefit package / relocation allowance / ex-pat taxation
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