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Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization; Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while
Ensure that studies are delivered on time, within budget, and in compliance with regulatory requirements and GCP standards. Support study start-up activities (feasibility, site selection, regulatory submissions). Coordinate investigator meetings and
You will drive medical initiatives within project teams, guiding strategic direction and decision-making processes, and offer expert medical and scientific guidance, leveraging therapeutic expertise in obesity studies to inform project development
You will be responsible for activities related to chemical intermediates, payload linkers, and drug linkers used in ADC development at Genmab’s partnered CMOs. You will work across project teams to support the CMC Project Managers and collaborate