• Develop integrated clinical pharmacology, DMPK, ADME, PK/PD, and model-informed development plans to support dose selection, study design, safety assessment, and regulatory submissions. • Support preparation for and participation in interactions with BfArM, EMA, FDA, and other relevant authorities, including development of clear scientific arguments and response strategies. • Advise on nonclinical , ADME, pharmacology, toxicology, and translational data packages to ensure they support clinical and regulatory objectives. • Manage and guide external CROs, pharmacometricians, PBPK vendors, DMPK laboratories, consultants, and other development partners. • Support strategic development planning, due diligence, partnering, and business development activities by identifying clinical pharmacology, DMPK, safety, and regulatory risks and proposing practical solutions.
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