Clinical Operations Belongs in the Boardroom, and Here's Why Biotech Can't Afford to Ignore It

Marissa Volpe, SVP of Clinical Development Operations at NervGen Pharma, makes a compelling case for elevating clinical operations from cost center to strategic boardroom voice.

For years, clinical operations has been treated as the back office of drug development: essential, expensive, but rarely invited to the table where strategic decisions are made. That's starting to change and, according to Marissa Volpe, SVP of Clinical Development Operations at NervGen Pharma, it needs to change much faster.

In a recent episode of Citeline’s “Small Biotechs, Big Decisions” podcast with Citeline VP of Clinical Solutions Claire Riches, Volpe made a compelling case for elevating clinical operations from cost center to strategic boardroom voice. Her argument is hard to refute: In an era where only about one in 16 drugs reaches the market, the last thing any biotech can afford is a trial that fails not because of the science, but because of poor operational execution.

More than project management

A common misconception is that clinical operations is simply project management: coordinating schedules, tracking milestones. Volpe pushes back hard on this. "It takes a village … but the backbone is clinops," she says. "It's not just about checking a box."

Claire Riches, Marissa Volpe

In a small biotech, Volpe says, clinops owns execution, data integrity, and quality, three pillars that determine whether a company reaches its next phase of development or runs out of runway. The clinical trial manager, she argues, is effectively the chief operating officer of a study, coordinating contract resource organizations (CROs), data managers, statisticians, medical monitors, site coordinators, and patients, all at once.

What makes this especially complex in biotech is the outsourcing layer. Unlike large pharma, small biotechs typically rely heavily on CROs to execute trials, particularly as programs expand geographically. Volpe's philosophy is to treat those CROs not as vendors, but as partners, building what she calls a "Velcro relationship" where every level of both organizations is connected, from CEO to project manager to clinical research associate.

"If you just have one link and it breaks, everything falls apart," she explains.

The protocol is the foundation of cost

One of Volpe's most pointed observations is about where overspending really begins: not in execution, but in protocol design. A poorly designed protocol, she maintains, drives costs up before a single patient is enrolled. "If you don't have a good protocol that's executable … your cost is going to go up," she says.

Data point complexity has surged. According to a Tufts Center for the Study of Drug Development (CSDD) study, total data volume continues to grow with 5.9 million datapoints collected on average per Phase III protocol, up 11% annually since 2020. Volpe advocates for including study coordinators as well as investigators in protocol reviews, as they are the ones who actually manage day-to-day patient appointments and assessments.

When asked how often she is given a "done deal" protocol with little room for input, her answer is blunt: about 95% of the time.

The Enrollment Myth

Another misconception Volpe tackles is that slow recruitment can be fixed by simply adding more sites. Another Tufts CSDD study indicates 37% of sites under-enroll and 11% fail to enroll a single patient. Adding sites doesn't solve the problem; selecting the right sites does.

"Just because you add more sites, it's not going to get you there quicker," she says, advocating instead for a diversified strategy focused on activating multiple high-potential sites simultaneously, rather than concentrating efforts on one or two.

She also makes a counterintuitive point about speed: A realistic forecast you can hit is worth more than an optimistic one you can't. Reliability and precision in enrollment projections ultimately serve boards and investors better than aggressive timelines that slip.

The Boardroom Gap

Despite owning the largest cost bucket in drug development and generating the data that drive every go/no-go decision, clinops leaders are rarely permanent fixtures in the boardroom. Volpe yearns to contribute more than just a study update.

"I wish I could stay and be part of what is getting the company to the next stage," she says. "Not just, ‘Here's an update.’"

She argues that boards, including venture capital and private equity members, should be asking clinops leaders about their biggest risks and assumptions, their site selection rationale, and the full outsourcing strategy, not just recruitment numbers. They should also understand what it would cost, in both time and money, to cut corners on operational infrastructure.

Her vision for boards: clinical operations represented not as a single slide in a quarterly update, but as a standing strategic voice, potentially through a chief clinical trials officer role, or by placing experienced clinops leaders directly on boards of directors. “I think it's so important that there's a direct voice into the C suite, or be represented at the C suite, and not be buried, kind of three levels down,” Volpe says.

What Comes Next

Volpe is realistic about how change happens. It requires education: helping CEOs, CMOs, and board members understand the scope and consequence of operational decisions. It requires champions who genuinely see the value. And it requires clinops leaders themselves to show up with data, examples, and strategic fluency, not just execution updates.

On artificial intelligence (AI), she's optimistic but measured. Automation can improve specific processes such as drafting informed consent forms and streamlining data queries, but it won't replace human judgment in a field that depends on real patients, real sites, and highly variable real-world conditions. "You still need that human input and that knowledge, the experience … human in the lead," she says.

The message to biotech boards is clear: Clinical operations is not a back-office function. It is the engine of drug development, the ultimate risk management unit, and the team whose decisions determine whether a company's science ever reaches a patient. Ignoring that voice at the board level isn't just an oversight. It's a strategic risk.