Senior Toxicologist, Non-Clinical Pharmacology Scientist

About the role

Sobi, a biopharmaceutical company focused on rare diseases, is looking for an experienced Senior Toxicologist, Non-Clinical Pharmacology Scientist to join its Preclinical Development and Translational Medicine (PDTM) department. The role covers Toxicology and Non-Clinical Pharmacology activities in projects supporting Clinical and Core Asset Teams, and is open to candidates based in Europe.

Key responsibilities

• Define and take overall accountability for Toxicology and Non-Clinical Pharmacology strategies and activities in assigned projects
• Share expert knowledge with cross-functional teams
• Prepare regulatory documents including IB, IND/IMPD summaries, RMP and briefing documentation
• Handle interactions with regulatory authorities on non-clinical pharmacology and Toxicology matters
• Manage preclinical safety studies in Contract Research Organizations: design, monitor, discuss and report findings
• Integrate translational aspects and communicate safety alerts from literature or studies to the benefit/risk team
• Carry out Toxicology assessments for impurities in drug products and support questions from manufacturing sites
• Take part in internal and external scientific communication, including oral presentations, posters and publications

Required profile

• PhD, DVM or equivalent in a relevant discipline, with at least five years of experience as a project toxicologist managing multiple projects across development stages
• Experience with biologics and small molecules is required; experience with oligonucleotides, gene therapy or combination drugs is a strong plus
• Fluency in written and spoken English

Required skills

• Extensive regulatory toxicology experience and a solid understanding of the drug-development process, including late-stage and lifecycle management of established compounds
• Immunotoxicology experience is a plus
• Board certification such as DABT/ERT is a plus
• Excellent communication and presentation skills, structured and results-oriented working style, good problem-solving and analytical mindset