Title: Toxicologist
Location: United States
The Toxicologist will play a critical role in the assessment of the safety profile of small molecule drug candidates throughout the drug development process. This position requires a deep understanding of toxicological principles, regulatory requirements, and the ability to interpret complex data to inform decision-making.
Responsibilities
- Conduct comprehensive toxicological evaluations of small molecules
- Analyze data from non-clinical studies to identify potential safety concerns and recommend strategies for risk mitigation.
- Prepare toxicology sections for regulatory submissions (INDs, NDAs) in accordance with FDA, EMA, and ICH guidelines. This will include liaising with the regulatory agencies related to toxicological data.
- Participate in project teams to provide expert advice on safety-related issues throughout the product lifecycle.
- Conduct risk assessments based on toxicological data to support decision-making processes regarding compound progression
Profile
- Ph.D. or equivalent degree in Toxicology, Pharmacology, or a related field
- Mulitple years experience in the pharmaceutical or biotechnology industry.
- Small molecules experience
- Strong knowledge of GLP regulations, ICH guidelines, and FDA/EMA submission requirements.
- Experience working directly with regulatory agencies is an advantage.
Benefits:
- Competitive salary with performance-based bonuses and comprehensive benefits package
- Home office option
- Excellent company culture