Associate Director, Clinical Research in Oncology and Translational Science @ Regeneron Pharmaceuticals, Inc.
Experts, Global Trial Manager @ Novartis Pharmaceuticals
SK Life Science, Inc. @
Clinical research scientist and project manager with over 10 years of experience in pharmaceutical development from high throughput screening to lead characterization, nonclinical and clinical development. Over 5 years of experience in clinical project management and clinical data analysis/interpretation. Competent with critical evaluation and data interpretation of multi-disciplinary projects. Has comprehensive knowledge of and experience with regulatory
Clinical research scientist and project manager with over 10 years of experience in pharmaceutical development from high throughput screening to lead characterization, nonclinical and clinical development. Over 5 years of experience in clinical project management and clinical data analysis/interpretation. Competent with critical evaluation and data interpretation of multi-disciplinary projects. Has comprehensive knowledge of and experience with regulatory guidance (GLP, GCP, ICH). Highly motivated with the ability to overcome challenges, develop and implement effective strategies and quickly adapt to new responsibilities. Capable with planning and coordinating multiple independent projects with emphasis on quality and timelines.
CLINICAL RESEARCH SCIENTIST @ CLINICAL OPERATIONS: As a clinical project manager, oversee clinical trials (Phases 1 & 2) throughout the lifecycle. Liaise with contracted vendors. Coordinate activities and meetings between involved vendors and project team to ensure timely and effective communication. Track progress of clinical trials ensuring projects meets timelines and quality expectations. Identify evolving project risks and communicate the risk to the project team in support of proactive planning. Review, compile, organize, and manage information gathered from the team and provide feedback and facilitate approval on clinical protocols and reports as well as all other trial related documents to ensure quality and integrity of the study. Develop and deliver progress reports and presentations to the multi-disciplinary project team. Train external clinical research team on the investigational product as a sponsor representative.
CLINICAL DATA ANALYSIS: Conduct comprehensive review, verification, and interpretation of pharmacodynamic (PD), pharmacokinetic (PK) & safety data. Assess consistency and accuracy of the data and resolve data discrepancies, errors and omissions for adequate reporting. Perform post-hoc and/or exploratory clinical data analyses to identify any issue related to the drug or to provide support for clinical study design and development plans. Prepare and present briefings and presentations on analytical findings and make recommendations to senior management and project team.
CLINICAL DEVELOPMENT SUPPORT: Research literature and interact with clinical vendors, investigators and key opinion leaders (KOLs) to explore and discuss options for clinical study designs in order to assess safety and efficacy of the investigational product. Actively participate and contribute to clinical study design and protocol development in collaboration with chief medical officer and program leader. From August 2010 to Present (5 years 5 months)
Doctors of Philosophy, Immunology @ Joan & Sanford I. Weill Medical College of Cornell University From 1997 to 2003 B.S., Food Engineering @ Yonsei University From 1987 to 1991 Hyunsil Han is skilled in: Life Sciences, Molecular Biology, Biochemistry, Clinical Trials, GLP, Immunology, Pharmaceuticals, Validation, Data Analysis, Strategic Planning, Microsoft Office, Clinical Project Management, Toxicology, Lifesciences, Pharmaceutical Industry
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