Key Responsibilities:

• Lead the design and execution of advanced oncology clinical pharmacology trials, managing studies of greater complexity in both scope and volume.
• Collaborate with cross-functional teams to determine dosing strategies, optimize schedules, and address drug-drug interaction challenges.
• Conduct quantitative pharmacology evaluations and provide insights throughout all stages of clinical development.
• Apply pharmacometric techniques to support drug development and tackle scientific inquiries.
• Take charge of drafting and carefully reviewing clinical pharmacology content for study protocols, reports, investigator brochures, regulatory submissions (e.g., IND, NDA), and responding to regulatory queries related to pharmacology.

Required Experience and Skills:

• Proven experience with various clinical study types, including first-in-human, proof-of-concept, and pivotal registration trials.
• Strong understanding of the drug development process, including model-informed drug development (MIDD) and the pharmaceutical R&D lifecycle.
• Advanced knowledge of pharmacokinetics (PK), pharmacodynamics (PD), PK/PD, Exposure-Response (ER), and quantitative systems pharmacology.
• Demonstrated expertise in quantitative analysis, with practical experience in modeling and simulation (e.g., NCA, population modeling, exposure-response analyses).
• Proficient in software tools for analysis (e.g., NONMEM, R, Simcyp, WinNonlin) and skilled in scientific graphing and PK modeling.