Project Toxicologist

Project Toxicologist

argenx

Ghent, Belgium

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.

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.