What Clinical Operations Should Know About Medical Affairs And MSLs

By William Soliman, Ph.D., BCMAS

As a medical director at a mid-sized pharmaceutical company, I finalized the clinical study protocol for the Phase 4 study we were going to embark on and was now ready to work with clinical operations to determine how we would recruit patients from clinical trial sites across the U.S. What I didn’t count on, was how difficult recruiting patients would be for the study. In the drug development ecosystem, clinical operations are often considered the engine that drives progress from idea to investigational reality. The discipline thrives on timelines, SOPs, protocols, and a culture of precision. But as the role of medical affairs (MA) continues to expand across the product life cycle from clinical development to post-launch, clinical operations professionals are increasingly expected to interface with medical science liaisons (MSLs) and MA colleagues in ways that go beyond handoffs and site logistics.

Having spent years in medical affairs and leading MSL teams, I’ve seen firsthand where these two critical functions – clinical operations and medical affairs – either thrive in collaboration or struggle in silos. While the goals are often aligned (improved patient outcomes, regulatory success, scientific rigor), the languages, structures, and workflows can be dramatically different.

If you're in clinical operations, here’s what you should know about MSLs and the broader medical affairs function and how strengthening this relationship can improve everything from trial recruitment to post-market data generation.

Understanding Medical Affairs: A Strategic Scientific Partner

Medical affairs is often called the “third pillar” of biopharma, sitting between R&D and commercial. But that oversimplifies a nuanced and increasingly strategic function.

Today’s MA teams:

• drive scientific communication with KOLs and HCPs,
• support evidence generation strategies, including real-world evidence (RWE),
• provide insights from the field to inform trial design and patient-centric endpoints, and
• navigate payer engagement, health economics, and medical education.

At the center of these efforts is the medical science liaison. Unlike CRAs or trial managers, MSLs engage with external stakeholders in a non-promotional, peer-to-peer scientific capacity. They are your boots-on-the-ground experts who often know what’s happening in a therapeutic area months before the data makes its way into a protocol.

Why ClinOps Should Care

1. MSLs Support Feasibility and Recruitment
   MSLs often have deep relationships with the very investigators you’re trying to recruit. Their preexisting rapport can make introductions smoother, feasibility conversations richer, and timelines shorter. Engaging MSLs early in site identification or protocol development can offer real-world perspectives that go beyond database feasibility models.
2. They Offer KOL Insights That Can Shape Trial Design
   Before the first patient is dosed, MSLs are gathering feedback from thought leaders about unmet needs, competing studies, and endpoint relevance. In my experience as a MSL director, working closely with clinical operations can make the difference between a successful clinical trial or a failure. If ClinOps loops them in during protocol development, it can prevent mid-study amendments and support better alignment with future publication strategies.
3. They’re Your Allies in Scientific Consistency
   ClinOps runs on precision. So does medical affairs, just in a different way. While you focus on data integrity and protocol adherence, medical affairs ensures that the scientific messaging to external audiences remains consistent and aligned with regulatory strategy. Together, you create a cohesive narrative from site to KOL to submission.  For a particular study I was overseeing as medical director, the insights that the MSL team was able to gather from the clinical trial site was highly valuable in helping us make some minor adjustments to how data was collected for a particular endpoint.

Bridging The Divide: Operational Lessons Go Both Ways

Medical affairs can learn a lot from clinical operations, particularly in standardization and documentation. But collaboration is a two-way street. Here's how clinical operations can adapt to work more effectively with MSLs and medical affairs teams:

1. Appreciate the Variability in the MSL Role

Unlike clinical operations, which is highly standardized across the industry, the MSL role varies by company, product, and region. Some MSLs focus on health economics and outcomes research (HEOR), others on early clinical data or post-market surveillance. Before making assumptions, ask: What does the MSL role look like in my organization? What are their core objectives this quarter?

2. Build Operating Norms Together

You likely have SOPs for vendor management and monitoring visits, but what about communication norms with medical affairs? Consider creating shared frameworks:

• Who attends which cross-functional meetings?
• How are trial updates shared with field teams?
• What’s the feedback loop between trial sites, MSLs, and ClinOps?

Establishing this clarity up front avoids duplication and confusion.

3. Formalize the Exchange of Insights

Clinical trial sites surface invaluable data not just for regulatory approval but also for scientific understanding. MSLs are often the ones synthesizing those insights into broader trends. Encourage structured debriefs between trial managers and MSLs. When insights flow in both directions, both functions become smarter.  This occurs when medical affairs has a seat at the table. For example, every time our company headed up a new Phase 4 study, medical affairs attended the investigator’s meetings to get to know the site coordinators and lead investigators, as well as to educate the sites with more in depth information regarding the drug’s mechanism of action, efficacy and safety.

4. Embrace Cross-Functional Training

Just as CRAs undergo regular GCP updates, consider joint sessions where clinical and medical affairs learn from each other. For example:

• MA can learn about protocol design constraints and eTMF documentation.
• ClinOps can better understand stakeholder mapping and scientific engagement principles.

It’s not about turning one function into the other; it’s about building empathy and fluency.

What Collaboration Can Look Like At Its Best

When clinical operations and medical affairs collaborate well:

• Sites feel more supported and engaged.
• Scientific feedback is looped back into development faster.
• Investigator relationships are stronger and more consistent.
• Launches benefit from insights that were gathered during development.

Think of MA and ClinOps not as separate domains but as two sides of the same scientific engine, one focused on data generation, the other on data interpretation and communication.

Toward Operational Maturity Across Functions

ClinOps has matured into a highly structured discipline, largely due to regulatory pressure. Medical affairs is evolving in the same direction but driven more by business need and scientific responsibility than by mandates.

As that transformation accelerates, clinical operations professionals have a unique opportunity to lead by example: sharing best practices in documentation, process design, and stakeholder coordination. In return, MA and MSLs bring external intelligence, therapeutic nuance, and strategic foresight.

By learning to collaborate not just at handoff points but from early planning through post-launch activities, these two functions can become exponentially more effective.

After all, the most innovative therapies don’t just reach patients because of good science. They succeed because the teams behind them were aligned, structured, and committed to delivering on the promise of medicine together.

About The Author:

William Soliman, Ph.D., is the founder and CEO of the Accreditation Council for Medical Affairs (ACMA) and the founder and CEO of White Manna Capital Partners, a biotech/pharma focused hedge fund. The ACMA is a leading life sciences accreditation, certification, and training company and established the first certification standards for prior authorization, reimbursement, pharma sales, medical science liaisons, and medical affairs professionals.

Dr. Soliman is a pharmaceutical industry futurist. In March 2021, he testified before the U.S. Congress’ Health Subcommittee about the pharmaceutical industry and the importance of professional standards for those who directly engage healthcare providers, such as sales representatives. Dr. Soliman is a former pharmaceutical executive who held leadership roles at several Big Pharma companies, including Merck, Johnson & Johnson, Abbvie, and Gilead.

He is routinely featured in national media outlets and received his Ph.D. from Columbia University and his bachelor’s degree from New York University.