Principal Scientist, Project Toxicologist

Role Summary

Principal Scientist, Project Toxicologist. Lead nonclinical safety strategy for early development projects, acting as a hands-on project toxicologist to deliver non-clinical strategies, studies and submission documents. Represent the PharmTox group in cross-functional early development projects and liaise with CROs and external partners. Based in Ghent, Belgium with on-site presence required several days a week.

Responsibilities

• Create early nonclinical safety screening strategies including data generation for the selection of relevant species to ensure smooth transition from discovery to IND-enabling studies
• Design, development and oversight of nonclinical safety package from IND/CTA through BLA
• Obtain buy-in from all stakeholders and ensure alignment with project team goals
• Follow up outsourced activities and discuss with experts at the partner companies
• Closely work with argenx study monitor and toxicology team on implementation of strategy, including planning, execution and close out of individual studies
• Ensure compliant execution of studies by study monitoring either in person or with support of 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
• Actively contribute to the development strategy at internal multidisciplinary project/clinical team meetings. Present and discuss work that is under responsibility of the PharmTox team
• Collaborate with medical writer and regulatory affairs in development of regulatory dossiers and the investigator brochure while ensuring nonclinical safety-related content is correct and comprehensive
• In collaboration with the program manager, ensure correct financial and project planning
• Together with Global Sourcing and Alliance Management and program managers, oversee the timely commission of studies to CRO

Qualifications

• You hold a Ph.D. or possess equivalent experience in the field
• Your academic background includes a degree in toxicology or equivalent
• A professional board certification in toxicology is preferred
• You have at least 4 years of relevant industry experience, with a solid track record in a similar position
• You have a solid understanding of nonclinical development of biotherapeutics
• You possess a solid understanding of GLP and ICH regulatory requirements
• You have experience in managing outsourced activities and working with external partners
• Your interpersonal skills are excellent, and you thrive in a multidisciplinary team environment
• You have at least 7 years of relevant industry experience, with a solid track record in a similar position
• You are proactive, flexible, and well-suited to work in a dynamic, fast-paced environment

Skills

• Nonclinical safety strategy design
• IND/CTA through BLA regulatory package development
• Study planning, execution and interpretation
• Regulatory dossier development and regulatory affairs collaboration
• Project management and cross-functional collaboration
• Outsourced study management and CRO liaison

Education

• Ph.D. in toxicology or equivalent field

Additional Requirements

• On-site presence in Ghent, Belgium several days per week; relocation to Belgium if not currently located there