Dr. Karen Smith is a biotech/pharmaceutical executive, board director and clinical/scientific advisor. Her breadth of experience covers 100+ clinical trials and 20+ 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, & Chief Medical Officer roles over the past 20 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 before transitioning to executive roles in several biotech and startup companies. Dr. Smith currently serves on the boards of Antares Pharma (ATRS), Sangamo Tx (SGMO), Emyria (EMD), and Capstan Tx. Previously, she served on the board of Forward Pharma A/S (FWD), Sucampo (SCMP), and Acceleron (XLRN), each resulting in over a billion dollar 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 from the University of New England (Australia), and an LLM (Masters in Law) from the University of Salford (UK). Dr. Smith 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.