Clinical Pharmacology Director

Join our team as a Director of Clinical Pharmacology, where you will provide expertise to cross-functional teams, conduct various pharmacokinetic analyses, design and run clinical studies, co-author regulatory documents, collaborate on non-clinical DMPK, and manage external CROs.

Key Responsibilities

• Provide clinical pharmacology expertise to cross-functional teams
• Conduct non-compartmental PK, pop PK, PK/PD analyses
• Design and run clinical pharmacology studies (food effect, DDI, AME)
• Co-author regulatory documents (protocols, study reports, IB)
• Collaborate on non-clinical DMPK and translational pharmacology
• Manage external CROs to ensure adherence to protocols and timelines

Required Skills & Qualifications

• PhD or PharmD with relevant training
• 6+ years' experience at Director level
• Strong PK/PD knowledge and drug metabolism
• Proficient in WinNonlin, NONMEM, R, and modeling software
• Experience in preclinical/clinical development of investigational drugs (small molecules/biologics)