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Dr. Karen Smith
Step Pharma, a global leader in CTPS1 inhibition for targeted cancer treatment, has appointed Karen L. Smith, MD, PhD, MBA, LLM, as its Chief Medical Officer (CMO).
Dr. Smith brings more than 25 years of leadership experience in the global pharmaceutical and biotechnology industries, having held senior executive roles at Bristol Myers Squibb, AstraZeneca, and Merck. She possesses deep expertise in clinical development, regulatory strategy, and medical affairs, with a proven track record of successfully overseeing over 100 clinical trials and achieving 20 regulatory approvals across diverse therapeutic areas, including oncology, cardiology, dermatology, rare diseases, and neuroscience.
Her strategic leadership has contributed to the global launches of small molecules, biologics, and medical devices, strengthening innovation pipelines and accelerating access to breakthrough therapies.
In addition to her new role at Step Pharma, Dr. Smith serves on the boards of several biotech companies, including Skye Bioscience and Context Therapeutics. She has also played a key role in delivering value through seven major corporate exits totaling nearly US$20 billion, notably Capstan Tx’s acquisition by AbbVie (2025, $2.1B) and Mariana Oncology’s acquisition by Novartis (2024, $1.75B).
Dr. Smith earned her MD from the University of Warwick (UK), PhD in Oncology from UCLA/University of Western Australia, MBA from the University of New England (Australia), and LLM from the University of Salford (UK).
Her appointment marks an important step in Step Pharma’s mission to advance precision cancer therapeutics and strengthen its clinical leadership on a global scale.
