• 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. • Support strategic development planning, due diligence, partnering, and business development activities by identifying clinical pharmacology, DMPK, safety, and regulatory risks and proposing practical solutions. • Collaborate closely with clinical development, regulatory affairs, CMC, nonclinical, safety, biomarker, and business development colleagues. • Experience with DMPK, ADME, PK/PD, PopPK, PBPK, exposure–response, dose selection, drug interaction strategy, formulation-related clinical pharmacology, safety ...
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