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The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest. Knowledge on antibody is a plus; Critically reads and evaluates relevant medical literature with deep understanding of the data and
Responsible for leading non‑clinical and early clinical pharmacology strategy across drug development programs. Provides expertise in PK/PD, modeling & simulation, and Model‑Informed Drug Development (MIDD) to support dose selection, study design, and
Accountable for assessing, establishing and operationalizing the regulatory strategy and execution plan for assigned IVD performance studies and for clinical trials that use IVDs, ensuring that study conduct and IVD use are compliant with the EU IVDR
Lead and develop the gastroenterology medical team, setting direction and fostering a culture of medical excellence. They will define and implement medical affairs therapeutic area (TA) strategy for gastroenterology, aligned with affiliate