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This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including
Lead comprehensive post-marketing surveillance activities including proactive monitoring, adverse event trend analysis, signal detection, and signal management for assigned veterinary products, ensuring compliance with global regulatory standards.
You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position
The candidate will serve as the bioanalytical expert for LC-MS and oversees outsourced LC-MS-based assay development, validation and sample analysis by bioanalytical vendors in support of regulated nonclinical and clinical studies for several of the
You’ll be leading a team of Pharmacometricians, from both a technical and scientific perspective, to ensure state of the art pharmacometrics approaches are applied to optimize drug discovery and development. Performing hands-on population PK/PD,