Skip to main content
2026 Global Regulatory Strategies Conference Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Tina Kim-Hafken, MSc

Vice President, Regulatory Affairs
Immunome, Inc.

Tina Kim-Hafken is Vice President, Head of Global Regulatory Affairs at Immunome, Inc. She has over 25 years of industry experience in process development, regulatory CMC and clinical regulatory with a focus in oncology. Tina has a strong track record of leading global marketing and clinical trial applications, negotiating innovative strategies and delivering regulatory approvals. Prior to Immunome, Tina served as Vice President of Regulatory Affairs at Harpoon Therapeutics, a subsudiary of Merck where she led regulatory strategy for oncologic T-cell engager immunotherapies. Previously, Tina was Senior Director of Regulatory Science and Global Regulatory Lead at Seagen Inc. (Pfizer) where she successfully led global submissions and approvals for TUKYSA® (tucatinib) for the treatment of metastatic HER2-postive breast cancer utilizing Project Orbis and Real Time Oncology Review. TUKYSA was the first marketing application approved through Project Orbis with simulaneous reviews by the United States, Switzerland, Singapore, Canada, and Australia. Before Seagen, Tina spent 12 years at Amgen Inc. serving as Global Regulatory CMC Lead for Aranesp® (darbepoetin alfa) and EVENITY® (romosozumab). Tina holds bachelor’s degrees in Chemistry and Music from the University of Kansas and a master’s degree in Biotechnology from Johns Hopkins University.

Presentation(s):