Xiaoting (Eileen) He
Group Leader / Medical Director @ Simcere Zaiming
About
● 10+ years of full-stage clinical development experience: Led 14 Phase I-II oncology trials and spearheaded a global multi-center Phase III gynecological oncology trial, simultaneously advancing NMPA/FDA/EMA filings. ● Proficient in multi-country regulatory communication: Led CDE Pre-NDA/NDA communications, participated in EMA SA meetings (Sweden/UK), and FDA Type C meeting/IND submission; familiar with multi-country filing regulations to efficiently advance registration processes. ● Outstanding team management experience (over 5 years): Managed team performance and conducted training; organized internal professional training in gynecology/oncology, with mature experience in mentoring and overall coordination. ● Strong cross-domain achievements: Covers gynecological health, multi-system oncology (urological/digestive/breast) and rare diseases; has published an SCI paper (IF 15), delivered 6 international conference presentations, and won several honors including the Merck Serono global cooperation award and the Asieris CEO Award. ● Solid academic and clinical foundation: Holds a Bachelor of Clinical Medicine and a Master of Obstetrics and Gynecology from Tongji University, with supplementary German studies. Served as a Resident Physician in Obstetrics and Gynecology at Tongji Hospital participating in the diagnosis, treatment and surgery of gynecological tumors.
China
Beijing
Pharmaceuticals
Medicine Development from IND to NDA, Communication with CDE/FDA/EMA, Good Clinical Practice (GCP), Statistical Data Analysis, People Management, American Association for the Certification of Training Program (AACTP), English as a Second Language (ESL), Certificate of medical practioner
Experience
Xiaoting (Eileen) He's Contact Information
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