Experience

YIRUI Pharmaceutical Technology

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief technical officer & medical officer (首席技术官&医学官; 副总经理)

  • Sep 2021 - Present

  We are focused on the development of novel drugs for the treatment of autoimmune diseases, complications of diabetes, infectious diseases and other chronic diseases. (我们的团队致力于发现和研究治疗自身免疫性疾病，糖尿病的并发症，感染性疾病 以及其它慢性疾病的创新药物。） We are focused on the development of novel drugs for the treatment of autoimmune diseases, complications of diabetes, infectious diseases and other chronic diseases. (我们的团队致力于发现和研究治疗自身免疫性疾病，糖尿病的并发症，感染性疾病 以及其它慢性疾病的创新药物。）



Biotest AG

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Manager Clinical Strategy & Development

  • Jun 2020 - May 2021



MorphoSys

• Germany
• Biotechnology Research
• 300 - 400 Employee

• Director, Clinical Program Lead

  • Dec 2019 - May 2020



Biotest AG

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Manager Clinical Strategy and Development, Corporate Clinical Research & Development

  • Mar 2014 - Nov 2019

  • Planning and conducting as well as evaluating national and international clinical trials Phase I to Phase III. • Developing, reviewing and editing study documents e.g. protocols, inform consent forms, case report forms, statistical analysis plans and database specifications, and medical monitoring plans. • Setting up Data and Safety Monitoring Board (DSMB), creating DSMB charter and reporting study data during DSMB meetings • Building and keeping the relationship to key opinion leaders • Editing and reviewing investigator brochure, clinical study reports, IND and safety annual reports (DSUR), carcinogenicity assessments white paper and paediatric investigation plan (PIP) for pipeline drugs • Publishing study results for Congress and in Journals • Providing medical and scientific supports in the field of life cycle management of already approved drugs. • Providing medical input in the evaluation of new indications and processing medical and scientific issues (including clinical development plans). • Providing Support to the creation and design of the global clinical development strategy in light of current medical knowledge, competition developments and future needs / Unmet medical need and its implementation in the form of development plans • Internal training on Asian culture Show less



Hexal AG

• Holzkirchen, Deutschland

• Clinical Study Manager

  • Jan 2010 - Jul 2012

  - Project planning and conducting: study design, planning and conducting bioequivalence studies; management of national and international CROs; contract negotiation with CRO; generating study protocol and application for approval of clinical trials by the authority and the ethics committee; coordinating of project activities and schedule with other departments - Monitoring the implementation of studies on site visit and monitoring status report of CROs - Quality control of the study report and laboratory results; - Supporting local studies in study design and protocol creation in Asian countries - Internal training on medical basics and Asian culture Show less



am Ersten Zentralen Krankenhaus Tianjin, V.R.China

• Tianjin City, China

• Assistenz-Ärztin der inneren Medizin

  • Sep 1998 - Jul 1999

  - Behandlung und Beobachtung stationärer Patienten mit Erkrankungen des Immunsystems - Analyse untypischer Symptome von Patienten anhand experimenteller Daten aus Blut und Knochenmark - Detaillierte Dokumentation von Symptomen und Entwicklung der Krankheit - Behandlung und Beobachtung stationärer Patienten mit Erkrankungen des Immunsystems - Analyse untypischer Symptome von Patienten anhand experimenteller Daten aus Blut und Knochenmark - Detaillierte Dokumentation von Symptomen und Entwicklung der Krankheit