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