This person will act as a senior scientific and regulatory advisor to HMNC, helping the team decide what data are sufficient, what additional studies are truly needed, how to justify dose and study design decisions, and how to communicate these decisions credibly to authorities such as BfArM, EMA, FDA, and other national competent authorities. • Develop integrated clinical pharmacology, DMPK, ADME, PK/PD, and model-informed development plans to support dose selection, study design, safety assessment, and regulatory submissions. • Advise on the need, design, interpretation, and regulatory relevance of clinical pharmacology studies, including formulation, food effect, drug interaction, QT/QTc, organ impairment, and special population assessments where applicable. • Prepare, review, and challenge key development and regulatory documents, including protocols, study reports, ...
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