Katherine Katherine Ku Kim
Regulatory Strategy/Policy leader and former FDA with proven experience to drive innovation through regulatory solutions
- Role
- Director, Global R & d Policy and Strategic Initiatives at Johnson & Johnson
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Katherine Katherine Ku Kim
As a global R&D policy and strategy leader, I help shape the global environment in which healthcare innovation is developed, regulated, and delivered. My perspective is grounded in prior work at the U.S. Food and Drug Administration (FDA), where I gained invaluable insight into regulatory decision-making, scientific assessment, and the evolving expectations for medical product development.I now apply that experience to drive enterprise-wide policy strategy, anticipate regulatory and scientific trends, and design a future-ready R&D framework. My work focuses on enabling innovation that is scientifically rigorous, strategically aligned, and positioned for successful global development. Areas of impact include- Integrating FDA and global regulatory insights into long-term R&D strategy- Regulatory and policy strategy for emerging technologies- Cross-functional leadership of complex enterprise strategic initiatives- Building multi-stakeholder coalitions across government, industry, and global health stakeholders- Translating complex regulatory/scientific landscapes into decision-ready guidance for leadershipI\'m energized by complex systems, cross-sector partnerships, and opportunities to create patient-centered impact.
Experience
Director, Global R & d Policy and Strategic Initiatives
Aug 2023 — Present · Washington, DC, US
Leading initiatives and partnering across the Johnson & Johnson enterprise to ensure development and implementation of global policy strategic priorities:• Drives key regulatory policy issues to foster R&D innovation across both pharmaceutical and medical device sectors• Leads cross-functional teams globally to develop J&J\'s economic and social impact footprints, advancing partnerships that support policy making and advocacy priorities. Developed and executed strategic business improvement plan to reduce resources needed by over 30%.
Education
University of Virginia
Biomedical Engineering
Duke University
Project Management Certification
Washington University in St. Louis
Bachelor’s Degree, Biomedical Engineering
University of Maryland
Master’s Degree, Public Health
Skills
- Quality Assurance
- Biotechnology
- Biomedical Engineering
- Medical Devices
- Clinical Research
- Laboratory
- In Vitro
- Fluorescence Microscopy
- Biomaterials
- Signal Processing
- Fda
- Lifesciences
- Clinical Trials
- Cell Culture
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