Principal Toxicologist

Job summary

The Principal Toxicologist will oversee the safety assessment of drug candidates from early discovery through clinical development. This role involves planning, designing, monitoring, interpreting, and communicating non-clinical studies in collaboration with multidisciplinary teams and external partners.

Qualifications

• DVM, Cand. Pharm, or equivalent scientific degree in toxicology or pharmacology (PhD preferred).
• At least 10 years of experience in preclinical drug development, ideally in the pharmaceutical or biotech sector.
• Strong understanding of global regulatory guidelines (ICH, FDA, EMA) and experience in toxicology strategy development.
• Expertise in authoring and reviewing regulatory submissions (IND, CTA, NDA/MAA) and supporting regulatory interactions.
• Extensive experience in toxicology study design, conduct, interpretation, and management of outsourced studies.
• Knowledge of biotechnology-derived pharmaceuticals and biological assessment of medical devices is a plus.
• Excellent communication and stakeholder management skills.

Responsibilities

• Develop and lead toxicology strategies for drug candidates across all phases of development.
• Design, monitor, and interpret nonclinical safety studies conducted at external CROs.
• Author toxicology sections of regulatory submissions, including INDs, CTAs, and NDAs/MAAs.
• Provide expert toxicological input to project teams and governance committees.
• Investigate and understand toxicological findings relevant to human safety assessment.
• Support risk assessment and benefit-risk evaluations in collaboration with clinical and regulatory affairs.
• Contribute to due diligence activities and evaluation of external opportunities.
• Enhance nonclinical safety assessment practices and internal guidelines.

Skills

• Strong toxicological background with a collaborative and curious mindset.
• Ability to generate high-quality nonclinical data and dossiers in a dynamic project environment.

Education

• DVM, Cand. Pharm, or equivalent scientific degree (PhD preferred) in toxicology or pharmacology.

Tools

• Familiarity with regulatory submission tools and toxicology study management platforms.