Director Toxicology

Director Toxicology

argenx

Ghent, Belgium

Within the PharmToxBA team we are looking for an experienced Director, Toxicology with a deep expertise in nonclinical safety testing of large molecule therapeutics. Profound experience with presentation of nonclinical safety data to Health Authorities is a must. The incumbent would be key team member of early development project teams and would be expected to actively contribute to discussions on best practices for creating and executing nonclinical packages to support clinical development strategies.

He/she will present nonclinical safety plans and outcomes to teams and management. argenx works in a network of partnerships and our toxicologists monitor their own studies or they partner with our study monitors to oversee the conduct of GLP studies. He/she will be an important contributor, author and collaborator in submission teams and needs to be able to review regulatory submissions and provide response to regulatory queries.

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. 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;
• 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.

Profile

• 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;
• While people management experience is an added bonus, what matters most is your ability to lead from within and inspire those around you;
• You are proactive, flexible, and well-suited to work in the dynamic, fast-paced environment of a rapidly growing biotech company.