The Journey of Building Medical Operations with Michael Kahn of Spark Therapeutics

When Michael Kahn moved into Medical Affairs in 2007, he wasn't aware of any operations excellence groups in the industry. Medical Operations is now a recognized function, yet leaders who build one still face the same early questions about what it should own, how to measure it, and who to hire.

In Episode 4 of OnPoint: The Medical Excellence Podcast, host Scott Thompson talks with Michael Kahn (Spark Therapeutics), who joined Spark in 2015 as the third person in its Medical Affairs department and began building its operations team in 2018. Medical Operations is the internally focused function that runs the shared infrastructure of Medical Affairs, which on Michael's team includes project management, medical, legal, and regulatory (MLR) review coordination, finance and contracting, and technology. Michael and Scott compare Medical Operations, Medical Excellence, and the Chief of Staff role, then cover how to measure an operations team's success, what a new leader should do first, which traits to hire for, and the signals that a head of Medical Affairs needs operational support. Michael also explains how his mentorship-driven leadership style creates time to develop his team. If you're building or rebuilding Medical Operations, start here.

Key Takeaways

• Labels shape influence. Michael sees "more overlap than less" among Medical Operations, Medical Excellence, and Chief of Staff, but notes that "the way a group or an individual is labeled can contribute a disproportionate amount to their ability to influence without authority in an organization, which is really key to success in this role." In his view, Medical Excellence "implies to me that a team is adding value outside Medical Affairs," while operations is "more internally focused to Medical Affairs."
• Put a metric on the board, then improve it. Michael is candid that "we have not solved this as an industry" when it comes to Medical Affairs metrics. Still, "it is important to put something on the board as a measure of success and think about continuous improvement in those metrics and we will get better at it." Industry data shows how much room remains: ZS estimates that 90% of Medical Affairs organizations consistently track activity, often through a CRM system, while about 50% measure how external stakeholder knowledge and beliefs are changing.
• Process metrics make operations value visible. After a comprehensive process improvement of MLR review at Spark, Michael's team measured "the number of days it took for a project to get from initial submission to all the way to the end" and saw expedited reviews come down. His reasoning on why that matters: "If a reviewer is crunched for time, they're more likely to miss something."
• Diagnose before you act. Michael advises new leaders to earn credibility through "open ears and closed mouth and talking to as many people as possible in order to build those networks and gain that credibility," then align with company culture and identify the centers of influence. A new operations excellence leader, he says, is ultimately a change manager.
• Hire for curiosity and adaptability. "I want to see curiosity. I want to see openness," Michael says, adding that a candidate's questions are "almost as or sometimes more important than the questions I ask them." He also looks for "adaptability of a communication style, because I think that's so important to change management and personal effectiveness."
• Constant firefighting signals a need for operational support. In Michael's words, "if a leader is finding themselves putting out fires non stop and being unable to focus on what they were brought in to do, which is usually strategy, they probably need, in effect, an internal Chief Operating Officer." Scott adds a practical test: a three-month calendar time audit to see whether a leader has any four-hour blocks for strategic work.

Resources Mentioned

The First 90 Days by Michael D. Watkins: Michael describes this Harvard Business School book as "a blueprint for immediate impact in an organization" and recommends it to professionals at any stage of their career.

About Our Guest

Michael Kahn was Senior Director, Medical Affairs Operations Leader at Spark Therapeutics at the time of this recording. His background spans journalism and more than 20 years in medical communications, from medical editing and agency publications work to leading client-side publication teams, before he joined Spark in 2015 to build its medical communications function and, from 2018, its Medical Affairs Operations team. He also serves on the business knowledge domain team of the Medical Affairs Professional Society (MAPS), which is developing a business curriculum for Medical Affairs professionals. Michael later returned to the show for Episode 17 with Chris McNabb (Bayer) to discuss defining, building, and scaling Medical Excellence teams.

Connect with Michael on LinkedIn: https://www.linkedin.com/in/kahnmichael/

FAQ

What is the difference between Medical Operations and Medical Excellence?
Michael Kahn sees more overlap than difference between the two. In his view, Medical Excellence adds value outside Medical Affairs by managing cross-functional work, such as communicating insights across the organization, managing KOL relationships beyond Medical, and integrating strategic planning with other functions. Medical Operations covers similar activities but is more internally focused on Medical Affairs itself.

When does a head of Medical Affairs need a Chief of Staff or operations leader?
According to Michael Kahn, the clearest signal is a leader who is constantly putting out fires and cannot focus on strategy. Other signs include needing to delegate organization-building work such as resource planning, interviewing, finance, and strategic planning, or having a clear, accepted vision with weak execution, such as missed deadlines, budget overruns, or activities misaligned across functions.

How do you measure the success of a Medical Operations team?
Michael Kahn starts with the success of Medical Affairs as a whole, since he views that as the success of operations. He recommends collecting specific written and verbal feedback from colleagues into a library that can be summarized for executives, alongside process metrics. At Spark Therapeutics, his team measured how many days medical, legal, and regulatory (MLR) review projects took from initial submission to completion and saw the number of expedited reviews come down.

What should a new Medical Operations or Medical Excellence leader do first?
Michael Kahn advises diagnosing before acting. That means building internal credibility by listening and talking with as many people as possible, aligning the approach with how the company and department communicate, make decisions, and follow procedure, and identifying the centers of influence whose support will matter when the leader begins to introduce change.

What traits matter most when hiring for Medical Operations?
Michael Kahn looks for curiosity, openness, good listening, and an adaptable communication style. He pays close attention to the questions candidates ask and treats a prescriptive, agenda-bound approach as a red flag. For more technical roles, deep Medical Affairs experience may matter less than tool expertise, as long as the candidate shows the capability and curiosity to learn.

Curious how this applies to your organization? Let's talk.

About OnPoint: The Medical Excellence Podcast

OnPoint: The Medical Excellence Podcast delivers insightful conversations on the most pressing issues facing top Medical Affairs professionals. Listen to stay ahead of industry trends and be inspired by leaders shaping the future of Medical Affairs.

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