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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.
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.
Responsibilities
* Create early non‑clinical safety screening strategies including data generation for the selection of relevant species to ensure smooth transition from discovery to IND‑enabling studies.
* Design, develop and oversee non‑clinical 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 non‑clinical 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.
Profile
* You hold a Ph.D. or possess equivalent experience in the field.
* Your academic background includes a degree in toxicology or equivalent.
* A professional board certification in toxicology is preferred.
* You have at least 4 years of relevant industry experience, with a solid track record in a similar position.
* You have a solid understanding of non‑clinical development of biotherapeutics.
* You possess a solid understanding of GLP and ICH regulatory requirements.
* You have experience in 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.
* You are proactive, flexible, and well‑suited to work in the dynamic, fast‑paced environment of a rapidly growing biotech company.
Offer
* You’ll work in a successful and rapidly growing biotech company, where we foster a dynamic and supportive work environment.
* This is a full‑time position; you’ll be part of a growing team with plenty of opportunities to make an impact.
* 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 also provide the possibility of working remotely, combined with part‑time on‑site presence in Zwijnaarde (Ghent), offering you flexibility in your work routine.
* If needed, we provide support for relocation and obtaining a work visa to ensure a smooth transition.
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.
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