Toxicologist

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 Originally posted on Himalayas