Karen joined Step Pharma as Chief Medical Officer in Sept 2025.
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) and rare disease (Defitelio). 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 clinical and business roles over the past 20 years including President, CEO, Global Head R&D, and Chief Medical Officer (CMO) at several Biotech and Pharma companies. She has built organizations from the ground up and managed large teams (>500 FTEs). Earlier in her career, she held senior leadership roles at Merck, Allergan, AstraZeneca and Bristol Myers Squibb before transitioning to C-level roles in several early stage Biotech Companies.
Dr. Smith currently serves on the Board of Sangamo Tx (SGMO), Skye Bioscience (SKYE), Context (CNTX) and ReFoxy Pharma, in addition to providing clinical and scientific advice for several companies.
Dr. Smith holds 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 (Aust), and an LLM (Masters in Law) from the University of Salford (UK).
