Principal Scientist, Project Toxicologist

The argenx PharmToxBA team is a functional expert group in the Development organization with expertise in nonclinical safety testing, operations of regulated studies and nonclinical and clinical Bioanalytics. We closely work with our colleagues from other functional areas and are part of multidisciplinary teams that are at the heart of argenx discovery and development. argenx works via a strong outsourcing model where scientific and quality oversight from the sponsor is an important part of our work. Our working language is English.

Within the PharmToxBA team we are looking for an experienced Project Toxicologist with demonstrated industry expertise in large molecule drug development. The successful candidate will represent the PharmTox group as a cross functional representative in early development projects where they will act as a hands-on project toxicologist to deliver non-clinical strategies, studies and submission documents. We expect 4 or more years of relevant experience on working in cross-functional project teams.

Project toxicologists at argenx support the development of our compounds from an early stage (lead optimization) up to submission for marketing and beyond. They are active members of the Early Development teams and late development Asset Teams. They design the nonclinical safety strategy in alignment with our stakeholders, present concepts and results to project teams and senior management. All our studies are conducted in partnerships with leading CRO partners. Interaction with our partners is a vital part of our daily work.

At argenx, we highly value co-creation and collaboration. Frequent personal interactions are central to our work culture.

Project toxicologists can be supported by study monitors and operational specialist for smooth conduct of nonclinical safety studies or they study monitor their own studies, depending on the workload. The project toxicologist is expected to significantly contribute to the authoring and review of regulatory documents and requests for information.

This role is based in Ghent, Belgium, and requires on-site presence several days a week. Therefore, candidates must be located in Belgium or be willing to relocate to Belgium, , as remote work from outside Belgium is not an option.

Along with your CV, we kindly ask that you submit a motivation letter that demonstrates why you're a great fit for this role.

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.

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