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The Emerging Biotech LeaderBiotechit's complicated. Author: SSI Strategy
Biotechit's complicated. A successful product launch requires grit, determination, and clear direction. But lets be real, the path to launch isnt a straight one. There are curves, hard turns, and dead ends. Heres the good news, you dont have to navigate the complexities alone. Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch. Language: en Genres: Business, Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it Trailer: |
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Clinical Operations as a Strategic Function
Episode 56
Tuesday, 2 December, 2025
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. Decisions relating to strategy, vendor performance, and data stewardship require sponsor ownership, supported by clear expectations for partners and defined routes for escalation. These elements establish the framework within which a CRO or other vendor operates. 4. Effective Oversight Systems Reduce Regulatory and Operational Risk Even with the right division of responsibilities, oversight must function in practice. Programs need structured processes for reviewing site conduct, monitoring outputs, and data quality to ensure issues surface early. When these checks are weak or inconsistent, avoidable problems can accumulate and lead to inspection findings or broader trial disruptions. 5. Emerging Leaders Benefit from Staying Curious and Involved Leaders are not expected to master clinical operations, but early engagement with clinical operations strengthens decision-making. It gives programs better visibility into resourcing, risk points, and the operational systems required to advance development. For a closer look at how these ideas play out in real development settings, listen to the full episode.
