Bioengineering / Biopharmaceutical

About This Role

This role involves assisting with quantitative pharmacology research and supporting early drug development strategies by analyzing PK/PD/safety information. It suits a candidate with a background in pharmacokinetics and strong analytical skills, working within a team environment.

Responsibilities

• Communicate with statisticians, data managers, clinical pharmacologists, clinical operations researchers, and external experts
• Assist in the comprehensive analysis of PK/PD/safety-related information for new drugs
• Conduct quantitative pharmacology research (modeling and simulation, population PK/PD, PBPK, MBMA studies, E-R relationships, etc.) to support early clinical trial discussions and early R&D strategy formulation
• Assist in preparing registration application materials for the clinical pharmacology section
• Assist in the design of clinical pharmacology-related protocols, data analysis, and results analysis, optimizing PK blood sampling and dosing regimens
• Assist in writing clinical trial protocols and the clinical pharmacology-related sections of registration application materials
• Collect and conduct preliminary summary analysis of preclinical and clinical literature
• Work in a team environment, participating in process improvement and SOP development
• Participate in client meetings

Requirements

• Master's degree in Pharmacy, Biological Sciences, Statistics, Mathematics, Physics, Chemical Engineering, Medical Engineering, or other related scientific fields
• Training in pharmacokinetic data analysis
• Strong analytical and technical writing skills
• Good written and oral communication skills
• Good organizational skills
• Work experience in modeling and simulation in the field of clinical pharmacology
• Proficient in WinNonlin, NONMEM, R, SAS, or other modeling and simulation software

About the Company

This position originates from Liepin.