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