Yasong Lu
Sr Director, Head of Pharmacometrics @Bicycle Therapeutics
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WORK HISTORY
Sr Director, Head of Pharmacometrics @Bicycle Therapeutics
Cambridge, MA, US
Lead and build the pharmacometrics team spanning pharmacometrics, programming, and data science functions supporting the discovery and development portfolio. Primary responsibilities: Formulate pharmacometric strategies and plans, and oversee their implementations and executions to enable MIDD for all programs Collaborate with partner functions, including clinical pharmacology, bioanalysis, translational sciences, medical, clinical operations, drug safety, DMPK, and discovery teams to identify and address program questions and challenges and advance the portfolio Author /coauthor regulatory documents, enable regulatory strategies, and participate in regulatory meetings related to clinical pharmacology and pharmacometrics topics (e.g, dose optimizations) Prepare budget and resource planning Establish and maintain pharmacometrics infrastructure and SOPs Lead recruitment in pharmacometrics and contribute to recruitment in clinical pharmacology function Mentor and develop junior staff to promote scientific excellence and individual development Engage and leverage vendors for pharmacometric activities and deliverables
EDUCATION
Shanghai Medical University
Master, Environmental Health
Shanghai Medical University
Bachelor, Preventive Medicine
Colorado State University
PhD, Toxicology
SKILLS
ABOUT YASONG LU
A seasoned quantitative drug developer with thorough understanding of the scientific foundation and techniques and passion for applying them to drug discovery and development Over 18 years of industrial experience in representing discovery PK/PD modeling (6 years) and clinical pharmacology/pharmacometrics (12 years) enabling programs of variable stages, ranging from early discovery to NDA submission and post-marketing management Strategic and technical excellence evidenced by professional achievements, including enabling regulatory approvals (Kisqali NDA, Tafinlar/Mekinist sNDA, Sotyktu NDA, Enhertu sBLA, Datroway BLA) and corporate licensing deals, and scientific publications Extensive experience and proficiency in setting and executing quantitative strategies (model-informed drug discovery and development, MIDD) for R&D programs, with hands-on experience in various modeling techniques, including PopPK, PK/PD, E-R, PBPK, model-based meta-analysis (MBMA), fit-for-purpose QSP modeling, clinical trial simulations Experience in and passionate about supporting and developing talents in pharmacometrics and quantitative drug development Experience in working with external service vendors and leveraging external resources to overcome internal resource restraints
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