How Clinical Operations Shapes Biotech Strategy

Clinical operations translates scientific research into the studies and data needed to bring new therapies to patients. In this episode of The Emerging Biotech Leader, host Ramin Farhood speaks with Sharon Arnold, a seasoned clinical operations executive with more than two decades of experience in both large pharma and emerging biotechs, about how operational leadership determines whether innovation reaches the clinic successfully.

Effective clinical operations extend well beyond trial execution. When the function helps shape the protocol early, by focusing on clarity, feasibility, and patient experience, teams stay aligned and data remain reliable. Building quality into each step reduces late-stage corrections and inspection risk.

For growing biotechs, the challenge is to scale without losing control. Success depends on choosing carefully what to build internally and what to outsource, while keeping direct oversight of data management, statistics, and the trial master file. These functions anchor the credibility of the program and protect the integrity of the evidence that supports it.

AI and data-driven tools are reshaping how feasibility and enrollment are planned. They can highlight new patterns in site performance and patient availability, but their value depends on interpretation. Data still needs to be tested against real-world conditions and reviewed by people who understand the therapeutic area, the protocol, and the practical limits of execution.

Patient inclusion should be built into operations from the start. Early collaboration with investigators and academic partners supports stronger site performance, while engagement with advocacy groups helps patients stay informed and invested in the study. Diversity and understanding are part of what makes a trial executable and its data meaningful.

Clinical operations sits at the intersection of science, strategy, and delivery. This conversation sheds light on what strong operational leadership really looks like: the decisions that prevent costly detours, the structures that sustain quality, and the mindset that turns a promising molecule into a viable medicine.

Catch the full conversation to hear how thoughtful operational leadership keeps programs on course and trials moving forward.