Job description
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
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.