Author: [AUTHOR] Published on 3/1/2025 12:00:00 AM
Sojeong Yi, PhD, Clinical Pharmacology Reviewer, US Food and Drug Administration, Rockville, Maryland
What does being the Cell, Gene, Regenerative Medicine & Nucleic Acid (CGRN) Community Vice Chair mean to you?
I am truly honored and privileged to serve as the Vice Chair of CGRN. My eight years of experience at the US Food and Drug Administration (FDA), particularly my recent transition to CBER from CDER, have deepened my interests in rare diseases and novel therapeutic modalities, including cell and gene therapies. I am excited to engage with leading experts from academia and industry in this rapidly evolving field, fostering valuable discussions and collaborations.
Recognizing the growing interest in cell and gene therapies among clinical pharmacologists and gene therapies among clinical pharmacologists and translational scientists, CGRN aims to host scientific sessions at ASCPT meetings and opportunities in these transformative areas of medicine and to advance the role of clinical pharmacology in the field.
What is your favorite society memory?
My first ASCPT Annual Meeting was in 2007 when I was a graduate student studying clinical pharmacology at Seoul National University in South Korea. My advisors, Drs In-Jin Jang and Kyung-Sang Yu, were incredibly supportive of my desire to learn about cutting-edge clinical pharmacology, so I made it a point to present my posters at ASCPT meetings almost every year, enduring a 14-hour flight from South Korea to the United States.
A standout moment for me was during a networking session at the 2015 meeting, where I met Dr. Hae-Young Ahn, the Deputy Division Director of Clinical Pharmacology-3 at the FDA at the time. Our conversation led to an interview opportunity for a clinical pharmacology reviewer position at the FDA, which ultimately drastically shifted my career trajectory. This experience underscored the importance of networking and active participation in the Society.
What has been the greatest challenge in your career?
One of the greatest challenges I faced was transitioning to the United States after moving from South Korea. The shift from being a research scientist to a regulatory reviewer was overwhelming. Although I was familiar with clinical pharmacology and drug development, I found myself swamped by US regulations, countless acronyms, and the different working culture and systems—all while navigating a language barrier.
Building a regulatory perspective took time, as it is quite different from the researcher's viewpoint. Initially, I often found myself working late hours, to the point where security guards in my building joked about me never leaving on time.
However, thanks to the support of my supervisors and colleagues at the FDA, I was able to adapt quickly and eventually establish myself as an independent reviewer.
What is the most important leadership lesson you have learned the hard way?
I have learned that leadership is not solely defined by titles or formal authority; it is about the ability to influence and inspire others. True leadership is about empowering others and driving positive change, regardless of your position.
Even without a designated leadership role, you can make a significant impact—so do not hesitate to step in and get involved. Influencing without formal authority is certainly more challenging, as it requires strategic communication and building trust.
When you are not working, how do you spend your free time?
In my free time, I enjoy gardening at a community garden, where I grow a variety of vegetables, including some Korean ingredients for making kimchi. I love using my harvest to make dishes like tomato sauce, pickles, and, of course, kimchi, and sharing them with my friends brings me happiness.
Interestingly, I often draw an analogy between gardening and our society: Just as a garden thrives on diversity and resilience in the face of unexpected weather changes, I believe our communities flourish when we embrace inclusivity and adaptability.
Dr. Yi has been a member of ASCPT since 2022.
