Senior Toxicologist

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The argenx PharmToxBA team is a functional expert group within 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 with an 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 Senior Toxicologist 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 part 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. We seek a person who can provide strong leadership and help us further develop our young and motivated team either as a direct people leader or as a coach and advisor.

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

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, 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
• Design a nonclinical safety package to align with the project team’s goals, ensure buy-in from all stakeholders, and provide guidance on how to effectively engage with Health Authorities to receive their feedback in a timely manner.
• Work closely with the argenx study monitor and the toxicology team to implement the strategy and execute the necessary studies.
• Follow up on outsourced activities, working closely with experts from partner companies to ensure everything is on track.
• Play an active role in shaping the development strategy during internal multidisciplinary project/clinical team meetings.
• Collaborate with the medical writer and regulatory affairs teams to prepare regulatory dossiers and the investigator brochure, ensuring that all nonclinical safety-related content is both accurate and comprehensive.
• Partner with the program manager to make sure the project’s financial and planning aspects are being handled properly.
• 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.
• Ensure that studies are executed in full compliance by monitoring them directly or with the support of the study monitor. Coordinate contributions from other sponsor disciplines, including CMC, Bioanalytics, and Pharmacokinetics.
• Work closely with other scientific disciplines to interpret the study results and present findings at internal multidisciplinary project team meetings and management forums.
 

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.
• 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 u