Project Toxicologist

argenx SE; Oost-Vlaanderen; Hybride; EUR 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Remote work option

On-site 2–3 days in Belgium

Incentives program

Résumé du poste

argenx SE is seeking an experienced Project Toxicologist to lead nonclinical safety strategies for multiple modalities, including large molecules. Based in Belgium with on-site presence, you will shape safety packages, coordinate CROs, and ensure regulatory readiness while collaborating across PharmTox and clinical teams.

The role requires a PhD in toxicology, 5+ years in industry, and strong GLP and regulatory knowledge.

Qualifications

• PhD in toxicology with industry experience.
• 5+ years in a relevant position within industry.
• Strong understanding of nonclinical development and regulatory guidelines (ICH).
• Knowledge of nonclinical development of biotherapeutics is a plus.
• Excellent GLP understanding and experience managing outsourced activities.
• Ability to work in multidisciplinary teams and communicate effectively.

Responsabilités

• Provide strategic guidance on nonclinical safety screening and testing strategies for candidate compounds.
• Contribute scientific expertise to PharmTox discussions on programs and study designs across modalities.
• Coordinate outsourced activities with partner companies and CROs.
• Design nonclinical safety packages to enable clinical programs and secure stakeholder buy-in.
• Advise on interactions with Health Authorities and regulatory feedback.
• Oversee study execution with study monitors and ensure compliant conduct of studies.
• Collaborate with CMC, Bioanalytics, and Pharmacokinetics to integrate study outcomes.
• Present PharmTox responsibilities and deliverables to project teams and management.

Connaissances

Toxicology

GLP Knowledge

Outsourcing management

Cross-functional teamwork

Regulatory liaison

Formation

PhD in Toxicology

Description du poste

About the role

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. argenx is seeking an experienced Project Toxicologist with expertise in the nonclinical development of multiple drug modalities, particularly with large molecules. Five or more years of relevant experience in cross-functional project teams is preferred. 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 core members of the early development teams and ad hoc members of asset teams. They design the nonclinical safety strategy in alignment with our stakeholders, present concepts and results to project teams and senior management. All argenx studies are conducted in partnerships with leading CROs. Healthy collaboration with our partners is a vital part of our daily work. As such, strong communication skills are key in this role. Project toxicologists can be supported by study monitors and operational specialists for smooth conduct of nonclinical safety studies or can monitor their own studies. The project toxicologist is expected to significantly contribute to the authoring and review of regulatory documents. The PharmTox team is a functional expert group within the development department of argenx with expertise in nonclinical safety testing and operations of regulated studies. We form a capability with our colleagues from nonclinical and clinical Bioanalytics (PharmToxBA), we work tightly together and exchange knowledge. We also closely work with our colleagues across 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. At argenx we value co-creation and work together as an empowered team to grow and accelerate our pipeline for patients with inflammatory and autoimmune diseases. Gent, Belgium is an important research hub where many members of the toxicology team (PharmTox) are located. Regular in-person interactions play an important role in how we work together and drive success. This role is based in Ghent, Belgium, and requires on-site presence 2-3 days per week.

Responsibilities

• Provide strategic guidance on nonclinical safety screening and testing strategies of candidate compounds,


• Contribute scientific expertise to PharmTox discussions on programs, reviews, and study designs across multiple modalities, including large molecules and emerging therapeutic platforms,


• Follow outsourced activities and collaborate with experts at partner companies,


• Design a nonclinical safety package that enables and supports the clinical program, be a key contributor in the ambitions of the project team, obtain buy-in of all stakeholders and advise on interactions with Health Authorities to secure timely feedback,


• Closely work with and advise the argenx study monitor and toxicology team on implementation of strategy, and execution and close out of studies,


• Ensure compliant execution of studies by study monitoring either in-person or with support of the 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 and management forums,


• Contribute to development strategy in internal multidisciplinary project and clinical team meetings, and present and discuss PharmTox responsibilities and deliverables,


• Collaborate with medical writing and regulatory affairs teams in development of regulatory dossiers and the investigator brochure. Ensure nonclinical safety -related content is correct and comprehensive, In collaboration with the program manager, ensure correct financial and project planning, Together with Sourcing and program manager, oversee the timely commission of studies to CROs. Participate in vendor alliance governance meetings as appropriate.

Profile

• PhD degree in toxicology or equivalent by experience,


• At least 5 years of industry experience in a relevant position,


• A solid understanding of nonclinical development and it’s relevant regulatory guidelines (ICH),


• Understanding of the specifics of nonclinical development of biotherapeutics is a plus,


• Excellent understanding of GLP requirements,


• Experience in managing outsourced activities,


• Excellent interpersonal skills; enjoying working in multidisciplinary teams,


• Proactive and flexible, able to operate in a dynamic surrounding of a fast-paced biotech company.

Offer

You'll become an empowered member a passionate team of cross-functional scientists building safe and effective treatments for patients with severe immune-mediated diseases, We offer a competitive salary package that comes with a broad range of benefits, The level assigned to this position will be determined based on the relevant experience of the final candidate, We provide the possibility of working remotely (from your home location in Belgium), combined with 2-3 days minimum on-site presence in Zwijnaarde (Ghent), offering you flexibility in your work routine. Our preferred start date is around December 2026, with some flexibility depending on the successful candidate’s availability.

The annual base salary hiring range for this position is €80,000.00 - €110,000.00 EUR. This job is eligible to participate in our short-term and long-term incentives program. The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future.

Equality & Diversity

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

Privacy

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Company

argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam.

There's more to discover at argenx, where our passion inspires bold possibility.