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Clinical Development Validate product safety and efficacy: Clinical Development Div. Clinical Operation Team Manager Ji Woong Lim

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Please tell us about your job at Celltrion.: I am tasked with operating and managing clinical trials for Humira. Our Clinical Operation Team is involved in all stages of clinical trials, from planning, application, and management, to reporting. We work with clinical research organizations (CROs) and researchers to ensure the effective operation of clinical trials. We also review clinical trials in and outside of Korea for their compliance with Good Clinical Practice (GCP) and applicable regulations.

What are the competencies and qualities required of your position?: Clinical trials are conducted on humans to verify the safety and efficacy of pharmaceutical products. Therefore, we need to ensure the health and safety of human test subjects. Having a corresponding sense of responsibility is equally important as having a basic understanding of clinical trials. Also required is English proficiency to communicate with researchers and CROs overseas. Attention to detail is also a huge plus.

What was your most memorable episode at work?: I took part in the FDA due diligence for the phase 3 clinical trials of Truxima. The due diligence involved organizations in Europe and the reviewers sent us a constant stream of requests and questions. With much help from our colleagues at Celltrion, we were able to successfully complete the due diligence despite the time difference between Korea and Europe.

Do you have any specific goals or visions? If so, what are they?: My short-term goal is to conclude the clinical trials of Humira and achieve approval early on. In the long term, I want to use my experience in various clinical trials to become a clinical trial expert.

Do you have anything to say to people looking for employment at Celltrion?: You spend a large portion of your life working for various employers, all of whom offer you numerous opportunities for growth. Celltrion also provides new challenges and a wide range of experience. If you seek personal and professional growth, you will find opportunities for new roles and advancement as the company carries out its biosimilar business in the global market and takes on new challenges.