Research Investigator
Core
Provide China clinical pharmacology and pharmacometrics strategy, modeling and simulation plans, and analysis to support early and late-stage drug development and regulatory submissions in China.
Role type
Senior IC clinical pharmacologist (pharmacometrics)
Builds
Clinical development plans, modeling and simulation (M&S) components, regulatory submissions (CTA/NDA)
Domain
Biopharmaceuticals, Clinical Pharmacology & Pharmacometrics
Required skills
Population pharmacokinetic analysis, exposure-response analysis, modeling and simulation (M&S), regulatory interaction support, cross-functional collaboration, study design and execution
Preferred skills
Global counterpart alignment, health authority response, drug development lifecycle knowledge
Technologies
Pharmacometric software, statistical modeling tools
Responsibilities
Develop CP&P strategy and plans for assigned projects, design and implement MIDD components including M&S plans, conduct PK/PD and pharmacometrics analyses, support CTA and NDA filings, liaise with global counterparts and functional teams
Seniority
Senior, hands-on IC