Zhenyi Xue

WORK HISTORY

EDUCATION

ABOUT ZHENYI XUE

I am an analytical life science research professional with over 20 years of experience and over 150 peer-reviewed manuscript publications leveraging clinical trial and real-world data (RWD) to generate evidence, support product success, and improve patient access.My background spans R&D and Medical Affairs, with expertise in designing and executing clinical development programs for drugs, medical devices, and diagnostics. I have contributed to regulatory submissions, health technology assessments, product launches, and lifecycle management across a diverse portfolio, including- Medical Devices & Diagnostics: Drug-eluting stents (DES) for cardiovascular disease, Viper LT™ System and Onclarity™ for HPV, FlowSmart™ and Swatch for diabetes care, MAX™ System for MRSA, Veritor™ for Flu A+B- Pharmaceutical Products: Glecaprevir/Pibrentasvir (HCV), Risankizumab (Psoriasis, PsA), Upadacitinib (RA, AD), Elagolix (Uterine Fibroids), Adalimumab (IBD, RA), Tafasitamab (DLBCL, FL), Ruxolitinib (GvHD, PV), Povorcitinib (HS, Vitiligo, PN), and Axatilimab (cGvHD).I bring deep experience integrating diverse data sources—including clinical trial data, patient-reported outcomes, digital health tools, wearable technology, complex health surveys, genomics, electronic health records (EHR), registries, and claims databases.With extensive medical congresses and manuscripts publications across immunology, dermatology, virology, infectious disease, genomics, oncology, hematology, cardiovascular disease, diabetes, and women’s health, I am committed to advancing scientific knowledge and meaningful healthcare outcomes.I also have a strong understanding of regulatory, ICH, and HTA guidance for both pharmaceuticals and medical devices, with hands-on experience in RWD/RWE, RCTs, PMOS, NIS, IIS, biomarker research, and translational science.Known for strong communication, collaboration, and business acumen, I excel in cross-functional, matrixed environments that value scientific integrity and strategic execution.