Senior Project Toxicologist

Senior Project Toxicologist

Idorsia Pharmaceuticals

Allschwil, Switzerland

This strategic role will be responsible for leading the nonclinical safety assessment of drug candidates across multiple therapeutic areas, from early discovery through to registration and beyond.

You will serve as the key toxicology representative on cross-functional project teams, providing expert guidance on safety strategy, regulatory interactions, and risk assessment. This is a high-impact role with visibility across the organization and the opportunity to shape the future of our pipeline.

• Job Responsibilities
• Lead nonclinical safety strategy for assigned drug development programs, ensuring alignment with regulatory expectations and internal standards.
• Design, oversee, interpret and report toxicology and safety pharmacology studies (GLP and non-GLP) to support candidate selection, and clinical development at all stages IND/CTA submissions, and global regulatory filings.
• Represent Toxicology on cross-functional project teams and governance bodies, providing expert input on safety risks and mitigation strategies.
• Prepare and review regulatory documents including IBs, INDs, CTAs, NDAs, and responses to health authority queries.
• Engage with global health authorities to support regulatory submissions and defend safety packages.
• Collaborate closely with colleagues in Pharmacology, DMPK, Clinical, Regulatory Affairs, CMC and other functions.
• Preparation of toxicological expert statements for impurities and excipients, cleaning validation, worker's safety 
• Liaising with key consultants and scientists in the field.
• Mentor junior toxicologists and contribute to the strategic development of the Nonclinical Safety department.

Candidate Requirements

• PhD, DVM, or equivalent in Toxicology, Pharmacology, Veterinary Medicine or related life sciences field.
• Minimum of 10 years of industry experience in nonclinical safety assessment, with a strong track record of supporting drug development programs.
• Proven experience in regulatory submissions and interactions with global health authorities.
• Deep understanding of toxicology study design, interpretation, and regulatory requirements.
• Excellent communication, leadership, and influencing skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Board certification (e.g., ERT, DABT) is highly desirable.
• Experience in multiple therapeutic areas with small molecules.
• Knowledge about SEND compliant documentation is desirable.
• Excellent command of English, both oral and written.