·Designs methodology of clinical pharmacology/pharmacokinetic within clinical studies, oversees PK analyses, reviews reports, and supports regulatory submissions;
·Conducts clinical pharmacology studies in compliance with regulatory requirements, insures working process following regulatory requirements and scientifically sound;
·Manages vendors with timelines, budgets and deliverables to ensure business excellence and quality of clinical pharmacology Performs or validates PK analyses;
·Participates in and contributes to drug development strategies; and interacts with regulatory authorities when needed.
·Ph.D. in pharmacology, toxicology, pharmaceutical sciences, or related discipline or Master with pertinent work experience in the pharmaceutical/biotech industry in clinical pharmacokinetics or a related discipline;
·Solid knowledge of clinical pharmacokinetic concepts and extensive working experience of clinical pharmacology programs and analysis software along with PK modeling;
·Good knowledge and understanding for DMPK related regulatory policies and guidelines;
·Excellent written and oral communication, interpersonal and problem-solving skills;
·Hands-on experience in physiologically based PK modeling and population PK analysis, or detailed knowledge of PK software (e.g. WinNonlin, Simcyp, NLME, NONMEM, etc.) is plus.
Contact Person：Ginny Ouyang