Project Toxicologist

About This Role

This Project Toxicologist role supports the development of compounds from early-stage lead optimization through marketing submission and beyond. The successful candidate will be a core member of early development teams and an ad hoc member of asset teams, designing nonclinical safety strategies and presenting concepts and results to project teams and senior management.

Responsibilities

• Provide strategic guidance on nonclinical safety screening and testing strategies of candidate compounds
• Contribute scientific expertise to PharmTox discussions on programs, reviews, and study designs across multiple modalities, including large molecules and emerging therapeutic platforms
• Follow outsourced activities and collaborate with experts at partner companies
• Design a nonclinical safety package that enables and supports the clinical program, be a key contributor in the ambitions of the project team, obtain buy-in of all stakeholders and advise on interactions with Health Authorities to secure timely feedback
• Closely work with and advise the argenx study monitor and toxicology team on implementation of strategy, and execution and close out of studies
• Ensure compliant execution of studies by study monitoring either in-person or with support of the study monitor
• Coordinate contributions of other sponsor disciplines (CMC, Bioanalytics, Pharmacokinetics)
• Collaborate with other scientific disciplines to interpret the study outcomes and present at internal multidisciplinary project teams and management forums
• Contribute to development strategy in internal multidisciplinary project and clinical team meetings, and present and discuss PharmTox responsibilities and deliverables
• Collaborate with medical writing and regulatory affairs teams in development of regulatory dossiers and the investigator brochure
• Ensure nonclinical safety-related content is correct and comprehensive
• In collaboration with the program manager, ensure correct financial and project planning
• Together with Sourcing and program manager, oversee the timely commission of studies to CROs
• Participate in vendor alliance governance meetings as appropriate

Requirements

• PhD degree in toxicology or equivalent by experience
• At least 5 years of industry experience in a relevant position
• A solid understanding of nonclinical development and its relevant regulatory guidelines (ICH)
• Excellent understanding of GLP requirements
• Experience in managing outsourced activities
• Excellent interpersonal skills; enjoying working in multidisciplinary teams
• Proactive and flexible, able to operate in a dynamic surrounding of a fast-paced biotech company