Hybrid Director, Toxicology

at argenx

• Job title: Director, Toxicology
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Ghent, Belgium

About the role

• Director of Toxicology overseeing nonclinical safety testing for biotherapeutics at argenx. Leading project teams and contributing to regulatory documentation and strategy for clinical development.

Responsibilities

• Advise on and create early nonclinical safety screening strategy 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 PharmToxBA 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.
• Present and contribute to discussions at senior management forums.
• Actively contribute to the development strategy at internal multidisciplinary project/clinical team meetings.
• 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.
• Provide guidance on how to effectively engage with Health Authorities to receive their feedback in a timely manner.
• Play an active role in shaping the asset development strategy during internal multidisciplinary project/clinical team meetings.
• Work with Sourcing and the program manager to oversee the timely commissioning of studies to CROs, and participate in vendor alliance governance meetings when appropriate.

Requirements

• You hold a Ph.D. or possess equivalent experience in the field.
• Your academic background includes a degree in toxicology or a related discipline.
• A professional board certification in toxicology is preferred.
• You have at least 7 years of relevant industry experience, with a solid track record in a similar position.
• You bring deep expertise in nonclinical safety testing and early-stage development of biotherapeutics.
• You possess a strong understanding of GLP and ICH regulatory requirements, which is essential for ensuring compliance in your role.
• You have experience 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.

Benefits

• competitive salary package with a broad range of benefits
• possibility of working remotely, combined with part-time on-site presence