Responsibilities:

• Possess a solid understanding of DMPK principles to guide CROs in completing preclinical DMPK packages that support clinical research or regulatory submissions.
• Collaborate with colleagues from other R&D departments (Chemistry, Toxicology, Pharmacology, Biomarkers, Clinical, etc.) and global regulatory teams to provide DMPK research support during drug development stages.
• Assist in the preparation and writing of various DMPK submission documents.
• Represent the team at internal governance meetings, advise on optimal approaches for regulatory reviews and program progression, and ensure compliance with guidelines from all health authorities concerning Development DMPK matters.

Requirements:

• Master's or Ph.D. degree in Pharmacokinetics or a related field; at least one year of work experience, with preference given to candidates with DMPK or large molecule PK submission experience.
• Ability to collaborate cross-functionally with colleagues and work independently.
• Strong scientific insight and problem-solving skills, meticulous attention to detail, and the ability to learn and adapt quickly.
• Excellent communication and writing skills in both Chinese and English.
• Proficiency in using GastroPlus, and familiarity with Excel, Word, PowerPoint, and other office software.

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