Principal Scientist, Project Toxicologist

Principal Scientist, Project Toxicologist

argenx

Ghent, Belgium

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.

Profile

• 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, collaborating effectively with colleagues from diverse areas.
• 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 the dynamic, fast-paced environment of a rapidly growing biotech company.