Bio

More than 15 years of experience combining extensive business strategy and scientific capabilities across biotherapeutics development areas including cell therapy, gene therapy, stem cell transplantation, monoclonal antibodies, Fc-fusion, Bi/Tri-specific Abs, nanobodies, and peptides. ✓ Championed innovation and operational excellence by influencing strategic vision and long-range planning and continually redefining and optimizing organizational structure and capabilities to create a competitive edge for the business. ✓ Steered multiple global cross-organizational committee to improve product/process design efficiency through dynamic effort from Research, Discovery, CMC, PKDM, Pre-clinical, Clinical Development, Quality, Supply Chain, and GMP manufacturing. ✓ Envisioned and instituted new agile cross-functional drug development roadmap and business strategy from target ID through pivotal clinical trials to accelerate speed to clinic and commercialization. ✓ Provided strategic and investment direction in emerging therapeutic areas and modality/platform technologies. ✓ Key member of due diligence team for cell/gene therapy pipelines, identifying, evaluating, and negotiating external partnerships that added value to the company. ✓ Built various business units/functions from scratch, implementing new facilities infrastructure, state-of-art technologies/platform, and operational/industrial guidelines. ✓ Hired, mentored, and managed global multidisciplinary teams of scientists and engineers; contributed to the development of the next generation of leaders and SMEs. ✓ Led regulatory filings at the clinical and commercial stages, including IND, BLA/MAA and leveraged in-depth knowledge of FDA, EMA, ICH guidelines, risk management, product changeover, and product/technology transfer processes.