Near 20 years profound global leadership in Oncology Clinical Research, Regulatory Filing, Product Launch, and Business Development at the prestigious pharmaceutical companies such as Merck, Novartis, Pfizer, innovative biotech Exelixis, well-established Asian pharmaceutical company Sihuan, and cell therapy start-up CARsgen. Holding in-depth knowledge and practical leadership skills to strategically manage cross functions and efficiently deliver the results and bet the company objectives in widespread areas, including but not limited to, Pharmaceutical Quality/CMC, Nonclinical Pharmacology and Toxicology, Global Clinical Development (early to late phase, innovative & generic), Global Regulatory Submission (NDA/BLA/aNDA), Global Commercial and Product Launch, Global Business Development (Licensing In/Out, Mergers and Acquisitions), and Asset Life Cycle Management.
Leading and being major contributor for multiple oncology global regulatory submissions, including one BLA, one NDA, two MAAs, and three INDs. Proactively planned and attended numerous TC/F2F meetings (i.e. post-IND, End of Phase 2, pre-BLA, pre-MAA, post-BLA orientation, etc) with FDA, EMA, and managed numerous response and interactions to address the inquiries from ROW regulatory agencies (i.e. SWISS MEDIC, Health Canada, Australia TGA, Japan PMDA/MHLW, China FDA, etc)