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. • Lead HMNC's clinical pharmacology and DMPK strategy across pipeline programs, ensuring alignment with clinical development, regulatory expectations, and future labeling considerations. • Support preparation for and participation in interactions with BfArM, EMA, FDA, and other relevant authorities, including development of clear scientific arguments and response strategies. • Experience with DMPK, ADME, PK/PD, PopPK, PBPK, exposure–response, dose selection, drug interaction strategy, formulation-related clinical pharmacology, ...
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