Step Pharma Appoints Dr. Karen Smith As Chief Medical Officer To Lead Clinical Development And Medical Strategy

Step Pharma, a global leader in CTPS1 inhibition for targeted cancer treatment, has announced the appointment of Karen L. Smith, MD, PhD, MBA, LLM as its new Chief Medical Officer (CMO), effective immediately. Dr. Smith brings more than 25 years of experience in the healthcare and biopharmaceutical industries, having held senior executive roles at some of the world’s leading companies, including Bristol Myers Squibb, AstraZeneca, and Merck. 

She possesses extensive expertise in clinical development, regulatory affairs, and medical leadership, and has successfully led over 100 clinical trials and secured more than 20 regulatory approvals across diverse therapeutic areas such as oncology, cardiology, dermatology, rare diseases, and neuroscience. Her leadership has contributed to the global launch of multiple small molecules, biologics, and medical devices.

In addition to her executive experience, Dr. Smith currently serves on the boards of several biotechnology companies, including Skye Bioscience and Context Therapeutics. Over the course of her career, she has played a key role in driving corporate growth and value creation, contributing to seven major company exits spanning preclinical to commercial stages, with a combined value of nearly US $20 billion. Notable recent transactions include Capstan Tx’s acquisition by AbbVie in 2025 for $2.1 billion and Mariana Oncology’s acquisition by Novartis in 2024 for $1.75 billion.

Dr. Smith earned her MD from the University of Warwick (UK), a PhD in oncology from the University of California, Los Angeles (UCLA) and the University of Western Australia, an MBA from the University of New England (Australia), and an LLM from the University of Salford (UK).

Andrew Parker, Chief Executive Officer of Step Pharma, welcomed her appointment, stating, “Karen’s passion for advancing innovative medicine, coupled with her extensive experience in leading clinical programs, will be instrumental in driving our mission to transform cancer and blood disorder treatment through CTPS1 inhibition. Her appointment as Chief Medical Officer, alongside the momentum from our recently completed Series C financing, positions Step Pharma strongly to advance the clinical development of dencatistat across multiple indications and deliver improved outcomes for patients.”

Expressing her enthusiasm for joining the company, Dr. Karen Smith said, “I am honored to join Step Pharma at this exciting stage in its growth and to contribute to the advancement of dencatistat, a first-in-class CTPS1 inhibitor with broad therapeutic potential. Step Pharma’s innovative ‘pipeline in a product’ approach provides a powerful framework for efficient clinical development and has the potential to deliver new treatment options to patients across a wide range of cancers and blood disorders. I look forward to applying my clinical and regulatory experience to help bring this transformative therapy to patients in need.”

Dr. Smith’s appointment marks an important milestone for Step Pharma as it continues to strengthen its leadership team and advance dencatistat—its flagship CTPS1 inhibitor—toward becoming a novel therapeutic option for cancer and hematologic diseases.