Yan Xu

About Yan Xu

Work collaboratively with Translational Sciences, Technology Innovation and Delivery, DMPK, Clinical Biostats, Clinical Development, Drug Safety, Project Teams and Program Management as a subject matter expert in quantitative clinical pharmacology• Apply hands-on expertise in non-compartmental pharmacokinetic analysis, oncology pharmacokinetic/pharmacodynamics (PK/PD), and pharmacometrics to characterize drug disposition and assess the dynamics of drug response to inform dose selection, schedule, combination, and go/no-go decisions• Work with global drug development team members to design, conduct, analyze, and integrate date from clinical studies, maintain study records and ensure study completion along program timelines• Work effectively as the clinical pharmacology representative on study teams.• Contribute dynamically to program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation• Working with cross functional teams for Acalabrutinib filling, contribute on drafting pre-clinical and clinical sessions documentation for NDA and regulatory agency response

Experience

1. Senior Principal Scientist - Clinical Pharmacology

   Genentech

   Oct 2022 — Present · San Francisco, CA, US

Education

• Texas Tech University Health Sciences Center

  Ph.D, Pharmaceutical Science

  2006 — 2011

• Shenyang Pharmaceutical University

  Bachelor’s Degree, Pharmacy

  1999 — 2004

Skills

• Clinical Development
• Drug Development
• Pharmacology
• Pharmaceutical Research
• Drug Delivery
• Pharmacodynamics
• Pharmaceutics
• Clinical Trials
• In Vivo
• Fda
• Drug Discovery
• Drug Metabolism
• Pharmacokinetics
• In Vitro
• Elisa
• Lc-Ms
• Glp