Yuan Liu

• Initiate the oncology global strategy for delivering regional development, drive cross functional cooperation to fulfill the regional clinic development strategy. • Play communication bridge between global asset team and regional, fulfill the registrational strategy, including CDP development, IND/NDA strategy, streamlining RFI process, secure the accelerating NDA approval. • Explore the opportunities for FIH project, dig out the global/local advantages and possibility for joining earlier phase and MRCT. • Budget control for each project, for saving cost; cross functional conflict resolution secure the result delivering and issue resolution.

• In Nephrology area: National leader engagement and interacting on accelerating patients’ enrollment; shortening the study period to fulfill the Internal analysis plan and securing the accelerating application in Healthy Authority. • Holding multiple workshops in Nephrology area and investigator meetings for engaging the investigators’ enthusiasm on continuing making efforts for accelerating the study period, keeping the drop off rate less than 6%. • Oversight vendors’ cost and quality including CRO, PRO, IVRS, IMP Supply, etc. Overall saving cost around 45%. • Leading and driving the cross-functional capability to make sure project running smoothly within policy and SOPs. Developing multiple plans including PMP, PDP, VMP and TMF plan etc. • People management: Keeping transparency and empowering subordinate for their ability and agility. Developing onboard plan, coaching and conducting 1-to-1 talk arming to improve the people’s ability on decision making and problem solving.

• Developing and executing operational strategies to cooperate with clinical sites for conducting both global and local clinical studies effectively. • Building up strong working relationship with hospitals; establishing long-term corporation which fulfills organizational strategy of reimaging medicines and operational excellence in clinical studies. • Improving cross-functional collaborations with internal (e.g. drug supply, DM, regulatory, CQA) and external (e.g. study sites, vendors, SMO and Heath authority) stakeholders to enhance productivity and mitigating risks. • Negotiating and signing 8 Master Trial Agreements (e.g. master agreements for clinical sites, vendors, SMO and CRO) to making the further corporation easily. • Budget planning and control, site start-up and patient recruitment, data quality, timeline management for major pivotal studies including Cardiovascular, Poc/Ph2b adaptive study in Nephrology, contributed global FPFV.

• Lead Phase 2-4 Novartis clinical studies, including but are not limited to PARADISE-MI (Ph3, Entresto post-AMI; CSM), Whole LNP023 Program includes (Ph3 IgAN, PNH, C3G; CSM), Ophthalmology study (Ph0 study; CSM), Ranibizumab (RVO/PM/AMD/DME; Lead CRA), NVA2309/QVA2331/QVA2318 (COPD; lead CRA), Xolair (IgE, Sr. CRA) and Myfortic (kidney transplant, Sr. CRA), etc.

• Safety and Risk management; SAE reports process; managing ARGUS database and narrative writing for phase 1-phase 4 clinical studies. • Collecting safety data for all the ongoing studies per Pfizer’s SOPs, conducting safety analysis for signal detections and management.

In university, I majored in pharmaceutical engineering, including pharmacology. Anatomy, organic chemistry, biochemistry, physical chemistry, Chinese medicine, Chinese pharmacy, and pharmaceutical industry, etc. Be familiar with the professional knowledge, understand the pharmaceutical industry principle and demand. At school, I led the team joining scientific and technological innovation projects and won the fourth prize.