Why Ops roles in biotech matter more than you think

Operational roles, like project or program management, can have an outsized impact on a biotech's likelihood of success... if the company understands this, cultivates the right talent, and incentivizes best practices/behaviors.

Life Science R&D: an expensive race to market

Two weeks ago, Iovance Biotherapeutics' stock plunged 32% – not because its newly approved melanoma treatment doesn't work, but because investors are concerned about its cash burn and financial runway. With $397 million left and quarterly expenses of nearly $280 million, the company is under pressure to execute efficiently. While high burn rates are not uncommon for late-stage biotech companies launching their first commercial product, Iovance’s financial position raises questions about whether it has enough runway to reach its next milestone.

This story is painfully familiar in biotech. We celebrate scientific breakthroughs but overlook a crucial truth: companies rarely fail because their science is marginally worse than their competitors'. They fail because they can't execute. The industry's graveyards are filled with companies that had promising drugs but ran out of runway. And although the pattern is clear, the lesson goes unlearned. Biotech companies continue to treat operations, program management, and regulatory strategy as support functions – necessary bureaucracy rather than core capabilities. They assume that if their science is strong enough, everything else will fall into place: investors will fund it, regulators will approve it, and the market will embrace it. 

Breaking this cycle requires a fundamental shift in how we view and value operations. Companies need to create dedicated spaces for these roles, invest in attracting top-tier talent to lead them, and position them as true strategic partners rather than support functions. And yet, too often, they don’t.

Emphasizing efficiency and operational roles alongside cutting-edge science

This blind spot runs deep in biotech culture. A YouTube video highlighting five six-figure jobs outside the lab reveals how pervasive the problem is. The comments tell the real story: "this is so helpful", "I'm trying to get out of the lab!", "tired of assays." These are scientists - many working at biotech companies - who weren't even aware these roles existed within their own organizations. When even the scientific workforce doesn't recognize the value of operational roles, how can we expect the industry to properly prioritize them?

This mindset creates a cascade of preventable crises. Companies set their sights on scientifically exciting but commercially impractical targets. They burn through cash too quickly, assuming future fundraising will be straightforward. They underestimate the complexity of patient enrollment in clinical trials. Leadership teams become entranced by platform technology without developing a clear asset strategy, leading to years of expensive exploration with no path to market.

The biotech ecosystem amplifies this problem by rewarding grand visions over operational excellence. But vision alone doesn't get drugs to patients. Investors increasingly need to believe not just in the science, but in a company's ability to execute with precision. That means maintaining discipline in cash management without stifling progress. It means treating patient stratification as both a scientific and business decision. It means viewing regulatory strategy not as a hurdle to clear but as a roadmap that shapes development from day one.

It goes beyond hiring good people in support roles. It's about recognizing that operational excellence is as crucial as scientific innovation. A brilliant Chief Scientific Officer needs equally capable program managers who understand how to pace spending, structure timelines, and efficiently track key data. They need regulatory strategists who can anticipate FDA requirements before trials begin. They need operations leaders who know how to extend runway without compromising progress.

The tech industry learned this lesson years ago – take SpaceX’s cost innovation. While their competitors focused solely on aerospace engineering, SpaceX recognized that operations would be their true competitive advantage. A telling example: their per-launch costs are projected to run 40 to 60 percent less than average. This isn't just about cost-cutting – it's about rethinking the entire operational model. Where traditional rocket manufacturers relied on a fragmented network of specialized suppliers, each adding complexity, cost, and time to the development process, SpaceX instead chose to build 85% of their rockets in-house. By investing in specialized equipment like friction welding machines for multi-level structural parts – investments that their competitors deemed too risky or expensive – they’re able to move much quicker than the competition.

Defining milestones, mapping paths to market, and data-driven PM

Building a successful biotech company requires the same operational rigor from day one. We’ve written before about how the best biotechs approach this challenge – they don't just move from milestone to milestone like levels in a video game. Instead, they map multiple paths to success, understanding that capital efficiency means having a comprehensive strategy that considers multiple regions, multiple indications, and multiple potential paths to market. Here’s what that could look like in action: 

• The best biotechs maintain an intimate, up-to-date understanding of what key milestones they’re pursuing, what data gets them there, and what experiments generate this desired data. Mapping data <> milestones and tracking progress is a priority, not a nice-to-have. These leaders implement tools and processes that support this way of working.
• Instead of just watching overall company spending, successful biotechs track money at a granular level – they know exactly how much each program costs, set specific warning points (like flagging when any project goes 15% over budget), and have clear plans for what to do when those warnings hit.
• Just as scientists obsess over experimental data, strong companies obsessively track operational metrics – they monitor how quickly clinical trial sites are enrolling patients, how often manufacturing batches succeed, and most importantly, use this information to make decisions before problems become crises.
• When it comes to the data itself, top performing companies understand that data is useless unless you can understand the context behind it: where did it come from, who generated it, under what conditions. 
• The best program managers aren't just scheduling meetings – they're building detailed plans that map out different scenarios (like what happens if the Phase 1 data is strong vs. moderate), helping teams pivot quickly when needed, and keeping development on track.
• Rather than frantically searching for manufacturers or vendors when they need them, successful companies build relationships with partners years in advance – they're willing to pay more for reliable partners who can grow with them, saving them from costly delays and quality issues later.
• Companies can consider tying advancement and compensation to operational excellence as much as scientific achievement. When a program manager who consistently delivers on time and under budget is valued as highly as a scientist making key discoveries, it sends a powerful message about organizational priorities.

This kind of operational rigor, when implemented thoughtfully, creates a competitive advantage that's hard to replicate. While others scramble to address manufacturing challenges or regulatory requirements reactively, companies with strong operational foundations can anticipate and plan for them, using their runway more efficiently.

Project and program management as intentional drivers of biotech R&D success

The talent to build these capabilities exists – we see it in the scientists eager to move beyond the lab, in the program managers mastering complex development pathways, in the operators who turn promising science into viable medicines. But until biotech embraces these roles as true drivers of success rather than support functions – they will remain underdeveloped, undervalued, and underfunded. 

Operational excellence isn't an accident; it’s a culture that must be built from the top down. Companies should be just as intentional about hiring world-class program managers, regulatory strategists, and operations leaders as they are about recruiting top-tier scientists. They should incentivize and reward behaviors that promote financial discipline, rigorous planning, and proactive problem-solving – not just scientific breakthroughs. And most importantly, they should embed these principles into their DNA from day one, ensuring that execution is never an afterthought. 

Every biotech company races against time. But it’s a special kind of heartbreak when promising treatments die from preventable causes – a bank account run dry, a trial poorly planned, a manufacturing delay that comes too late to fix. Science can light the way forward, but it takes operations to carry that light to patients. 

Kaleidoscope is a software platform for biotechs to robustly manage their R&D operations. With Kaleidoscope, teams can plan, monitor, and de-risk their programs with confidence, ensuring that they hit key milestones on time and on budget. By connecting projects, critical decisions, and underlying data in one spot, Kaleidoscope enables biotech start-ups to save months each year in their path to market.