We are seeking a senior Clinical Pharmacology expert who can combine deep pharmaceutical industry experience with a strong understanding of regulatory authority expectations. 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. • Interpret clinical and nonclinical pharmacology, PK, safety, exposure–response, and modeling data and translate them into pragmatic, regulatorily defensible development decisions.
mehr