GARY LIN

I have over 8 years of experience in clinical research and drug development, with extensive experience in IND submissions in Taiwan, China, and the United States, as well as clinical trial operations across Taiwan and China. My expertise lies in new drug development, clinical project management, and cross-functional collaboration throughout the drug development lifecycle.

I have successfully supported and led clinical programs from early development stages through clinical execution, including the development of clinical trial strategies, preparation of trial synopses, coordination with investigators and key opinion leaders (KOLs), and management of internal and external stakeholders. I am experienced in designing clinical trial concepts, communicating effectively with physicians, regulatory authorities, and cross-functional teams, and driving projects toward key milestones.

As a project leader, I have built and managed a clinical team of six members across multiple projects, fostering collaboration and ensuring successful execution of clinical objectives. Through effective leadership, strategic planning, and operational management, I have delivered multiple clinical development achievements while maintaining quality, timelines, and budget objectives.

• CytoArm biotech, Senior Clinical Project Manager, 2024-01-01, Now, Responsible for the integration of the clinical, preclinical, and CMC departments, including reviewing preclinical study content, assessing gaps in related experiments, and participating in the drafting of CMC documents., Responsible for drafting clinical trial protocols, investigator’s brochures (IB), informed consent forms (ICF), and other documents, as well as for the selection of domestic and international CROs.
• Gongwin Biopharm, Director of clinical research department, 2019-01-01, 2024-01-01, Responsible to draft business plan, budget control, indication developments, start up clinical research in study center, monitor project progress, assist to product promotion and design trial synopsis.
• BIOHOPEKING CORPORATION, Clinical Manager, 2019-01-01, 2019-12-31, Responsible to phase 2 trial submission and wrap the documents of all CTD modules.
• Mello Biotech, Project Manager, 2017-01-01, 2019-12-31, Responsible to summarize pre-clinical data, design phase 1 trial, negotiate with CDMO and CRO.