Clinical Operations as a Strategic Function

Clinical Operations as a Strategic Function

From The Emerging Biotech Leader by SSI Strategy

December 2, 2025 · 21 min · Episode 56

About this episode

This episode discusses the strategic role of clinical operations in biotech and pharma, emphasizing early engagement and cross-functional collaboration.

In this episode of Emerging Biotech Leaders , host Ramin Farhood speaks with Meaghan Powers , Senior Director of Clinical Operations at SSI Strategy. With deep experience across biotech, pharma, and consulting, she offers a clear view of where clinical operations drives strategic value and how early engagement can set emerging biotechs up for success. Key Themes and Insights 1. Clinical Operations Is a Strategic Function Clinical operations is often misunderstood as a task-driven, execution-only role. In reality, it requires strategic planning early in development, including anticipation of regulatory expectations, operational risks, and study feasibility well before a protocol is finalized. 2. Early Cross-Functional Input Prevents Downstream Problems Strong clinical programs benefit when core scientific, operational, and quality perspectives are brought together early. Aligning these functions at the concept stage helps shape feasible early-phase designs and creates more stability as the program moves into later development. 3. Sponsors Cannot Outsource Accountability Certain operational tasks can be outsourced, but responsibility for the trial remains with the sponsor…

People in this episode

Host: Ramin Farhood

Guest: Meaghan Powers

Topics covered

  • clinical operations
  • strategic planning
  • biotech
  • pharma
  • cross-functional collaboration
  • regulatory expectations

Keywords

  • clinical operations
  • strategic value
  • biotech success
  • regulatory expectations
  • operational risks
  • study feasibility
  • cross-functional input
  • sponsor accountability

Mentioned in this episode

Organizations: SSI Strategy

More episodes of The Emerging Biotech Leader

Explore listener stats, chart rankings, contacts and more on the The Emerging Biotech Leader podcast page.