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You will oversee the execution of one or more clinical trials across different therapeutic areas and development stages, ensuring high-quality and timely deliverables. Participate...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
The candidate will serve as the bioanalytical lead for one of the argenx compounds, represent the bioanalytical team in one or multiple project teams, and closely collaborate with...
Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the...
Primary activities will focus on Medical Monitoring Delivery & PV Support. The medical monitor will independently deliver all medical support required for successful delivery of...
Provides global regulatory leadership of assigned program(s); Develops global regulatory strategies, including risk assessment and mitigation strategies; Participates in strategic...
Optimize nonclinical development plans for products. Collaborate with project/asset teams to deliver optimized development plans. Handle non-clinical drug safety aspects in various...