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. We are seeking a senior Clinical Pharmacology expert who can combine deep pharmaceutical industry experience with a strong understanding of regulatory authority expectations. • Provide senior oversight of PopPK, PBPK, PK/PD, exposure–response, and other quantitative pharmacology activities, including critical review of vendor outputs, assumptions, and conclusions. • Strong scientific writing, communication, and stakeholder-management skills, with the ability to explain complex clinical pharmacology and DMPK topics clearly to cross-functional ...
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