You have a proven track record in protocol development, regulatory submissions (IND, CTA, BLA, MAA), and clinical data interpretation, and are recognized as an expert in the end-to-end process of clinical data generation, from protocol design through to final reporting * A key focus lies in ensuring the generation of high-quality clinical data and supporting the preparation of regulatory submissions (e.g., IND, CTA, BLA, MAA). * You demonstrate comprehensive expertise across the clinical data lifecycle—working backwards from the desired final readouts to plan early for the necessary data, overseeing capture, coordinating cleaning and integrity checks, and obtaining study results in collaboration with biostatistics, programming, data management, and me
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