Karen L. Smith, M.D., Ph.D.
Dr Karen L. Smith, M.D., Ph.D. is a Biotech/Pharmaceutical Executive, Board Director and Clinical/Scientific Advisor in the US, Europe, Canada and Australia. Her breadth of experience covers over 100 clinical trials and 20+ major regulatory approvals in multiple jurisdictions including FDA (USA), EMA (Europe), TGA (Australia), ANVISA (Brazil), and PMDA (Japan); leading to product launches across diverse therapeutic areas including oncology (Herceptin, Vyxeos), rare disease (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox, Aczone), neuroscience (Abilify, Solriamfetol), and anti-infectives (Teflaro). In addition to growth and creation of R&D pipelines, Dr Smith’s successful record of business development includes acquisitions, divestitures, and partnership deals.
Dr. Smith has held various President, CEO, Global Head of R&D, and Chief Medical Officer roles over the past 15 years. She has built companies from the ground up and is a strong advocate for women in science and diversity in the Boardroom. Earlier in her career, she held senior leadership roles at Allergan, AstraZeneca and Bristol Myers Squibb. Dr. Smith also currently serves on the boards of Antares Pharma (ATRS), Sangamo Therapeutics (SGMO), Acceleron Pharma (XLRN), Aummune and Capstan Therapeutics. Previously, Dr. Smith served on the board of Forward Pharma A/S and Sucampo Pharmaceuticals, Inc. each with a successful corporate exit through acquisition.
Dr. Smith holds several degrees, including an MD from the University of Warwick (UK), a PhD in Oncology from UCLA (USA)/UWA (Australia), an MBA (Masters in Business) from the University of New England, and an LLM (Masters in Law) from the University of Salford (UK). Dr Smith also holds British and Australian citizenships and is a US Permanent Resident. In her spare time, she hikes, bikes, skis, and is a competitive triathlete who has completed several Ironman distance races.