This article originally appeared as part of The Vendor Edge series on LinkedIn. This is an expanded and updated version for kieranengels.com.
Strategy without execution accountability is theatre. Biotechs and VCs focus on scientific strategy and capital allocation but consistently underweight execution infrastructure. The companies that succeed in clinical development are not the ones with the best science. They are the ones with the clearest governance, the strongest vendor oversight, and the most honest assessment of their execution capability. Execution is not downstream of strategy. It IS strategy. The difference between biotech companies that get drugs to market on time and budget and ones that spiral is not science. It’s execution discipline.
KEY TAKEAWAYS
Key Takeaways
- Strategy without execution accountability is unfunded wishful thinking. Biotech success hinges on execution infrastructure, not just science.
- Vendors don’t fail because of capability gaps. They fail because sponsors haven’t defined what success looks like or how accountability works.
- Biotech teams that move fastest have clear governance, defined decision rights, and honest assessment of their own execution capability.
- VCs and biotech founders often underestimate the cost of poor vendor management. It compounds faster than capital burn.
- Execution strategy includes vendor selection, governance clarity, and decision-making infrastructure, not just scientific objectives and timelines.
The pitch is always the same. Brilliant science. Clear pathway to IND. Strong management team. Compelling market need. VCs hear it and fund it. Then somewhere between kickoff and first-in-human, things get complicated.
Understanding the Fundamentals
The science is still good. But timelines are slipping. Vendors are missing deliverables. There’s confusion about who’s accountable for what. Leadership is in constant firefighting mode. The company is burning through capital faster than anyone projected, not because the science failed but because the execution infrastructure wasn’t built to support the strategy.
This is what Kieran Engels sees repeatedly: Biotech teams and their investors have a strategy problem that looks like an execution problem. The real problem is that execution was never treated as strategy.
The Real Cost of Misalignment
Here’s the truth. The difference between a biotech company that gets a drug to the clinic on timeline and budget and one that spirals is not the quality of the science. It’s the clarity of the governance. It’s whether there’s a real feedback loop between what’s happening in execution and what the leadership team knows. It’s whether vendors understand what they’re supposed to deliver or just think they do.
Biotech companies and their investors spend months refining scientific strategy. They run market analyses. They model capital allocation. They debate the molecular basis of the disease. And then they treat execution like a checklist item. They assume that good people with a good science will somehow automatically execute well.
Building Governance Infrastructure
That assumption is wrong. Good science requires good execution infrastructure. Without it, the science never reaches the market. The science doesn’t fail. The timeline fails. The budget fails. The vendor relationships fail.
Let’s be clear about what execution strategy actually includes. It’s not just timelines and budgets. It’s vendor governance. Which vendors can actually deliver what you need? How will you know if they’re delivering it? What’s your decision-making structure? How will you catch problems early? If these questions aren’t answered before you start, you’re not executing strategy. You’re hoping.
The Speed Advantage
Seuss+ works with biotech teams to build execution strategy that actually supports scientific strategy. It’s not about adding overhead. It’s about preventing the hidden costs that come from vendor misalignment, scope drift, and leadership distraction.
One of the biggest mistakes biotech teams make is underestimating the cost of poor vendor management. They see vendor costs as a percentage of budget. But when a vendor misaligns with what you need and doesn’t deliver on time, the cost compounds. It’s not just the vendor cost. It’s the delay to your IND timeline. It’s the capital burn while you’re waiting. It’s the opportunity cost of the market window closing. Poor vendor management can destroy the financial model of a biotech company.
The other mistake is treating execution as a problem to be solved with more management. More project managers. More status meetings. More reports. That’s not execution strategy. That’s overhead. Execution strategy is clarity. Clear governance. Clear decision rights. Clear accountability. When those things are in place, a smaller team executes better than a larger team without them.
This is also why VCs should care about execution strategy as much as scientific strategy. A company with good science and bad execution infrastructure will fail. A company with good science and clear execution infrastructure will get the drug to the market on timeline and budget. The difference is not in the science. It’s in the infrastructure.
Kieran Engels has worked with biotech teams that had weak execution infrastructure and tried to compensate by hiring more people. It doesn’t work. You just hire more people in a dysfunctional system. What works is fixing the system. Getting clear on decision rights. Getting clear on vendor accountability. Getting honest about execution capability and building infrastructure around that.
The companies that move fastest are not the ones with the biggest teams. They’re the ones with the clearest governance. They’re the ones where the vendor understands exactly what they’re supposed to deliver. They’re the ones where leadership has visibility into execution without constant escalations. They’re the ones that catch problems early because there’s a feedback structure in place.
Speed without execution infrastructure is just panic in a different disguise. Speed with clear governance, strong vendor oversight, and honest assessment of capability is real acceleration. That’s the difference between biotech companies that succeed and ones that don’t.
Strategy-Only Approach vs. Execution-Integrated Approach
| Dimension | Strategy-Only (No Execution Infrastructure) | Execution-Integrated (Governance-Aligned) |
| Vendor selection | Selected on reputation and responsiveness | Selected on operational alignment with decision-making and governance model |
| Accountability | Assumed but not defined; conflicts emerge mid-execution | Clear KPIs, decision rights, escalation path defined at contract |
| Timeline management | Project timeline drives execution; reality ignored until slipping | Execution capability informs timeline; assumptions tested and tracked |
| Decision-making | Constant escalations; no clear authority structure | Decision rights defined upfront; escalations prevented by clarity |
| Risk management | Risk treated as problem to control; buried until crisis | Risk treated as information; signals read and addressed early |
| Leadership overhead | 50%+ leadership time on firefighting and escalations | 20% or less leadership time on execution; focus on strategy |
| Vendor management | Reactive problem-solving; rework cycles; relationship tension | Proactive alignment; clear expectations; collaborative problem-solving |
| Hidden costs | Scope drift, rework, timeline extension, opportunity cost | Minimal; problems caught early; execution predictable |
| Time to market | Longer; unpredictable; compounds with complexity | Faster; predictable; scales with clarity not team size |
The difference between biotech companies that succeed and ones that spiral isn't the science. It's the execution infrastructure. Execution is not downstream of strategy. It IS strategy.
Key Industry Data
Trial delays cost sponsors $600,000 to $8 million per day in lost revenue opportunity. (Source: Tufts CSDD)
FDA issued 303 warning letters in FY2025, a 59% increase from 190 in FY2024. (Source: FDA)
The FDA formally adopted ICH E6(R3) on September 9, 2025, shifting the regulatory standard from routine monitoring to risk based, proportionate oversight. (Source: FDA)
Per patient costs in clinical trials range from $113,000 to $136,000 depending on therapeutic area and phase. (Source: IQVIA)
Clinical trials cost between $4 million for Phase I and over $100 million for Phase III programs. (Source: Industry benchmarks)
Frequently Asked Questions
Show them the financial impact. A six-month timeline delay from poor vendor execution costs millions in burn and opportunity cost. That’s a strategic failure, not an operational one. When leadership sees the financial impact of poor execution infrastructure, they prioritize it differently.
You can retrofit it, but it is costly and difficult. The cleanest way is to build it at the beginning. The companies that move fastest are the ones that spend weeks getting governance clear before they start. That investment prevents months of downstream problems.
Ask them. Really ask them. What’s their experience managing vendors? How have they handled complexity before? What governance structures do they have? If they’re vague or defensive, they probably haven’t thought it through. The teams that move fast can articulate their execution capability clearly.
No. It speeds them up. Yes, it requires upfront investment in governance clarity. But that prevents the constant stops and starts that come from discovering misalignment mid-execution. The biotech teams that move fastest are the ones who got execution strategy clear first.
Ask about their vendor strategy, not just their scientific strategy. How will they select vendors? How will they know if vendors are delivering? What governance will they put in place? How honest are they about what they can execute vs. what they need to outsource? The answers tell you whether they’re ready to execute their strategy.
About the Author
Kieran Engels is CEO and Co-Founder of Seuss+, a strategy and execution partner helping biotech sponsors optimize vendor relationships across clinical development. With more than a decade of experience in vendor governance, risk management, and clinical trial execution, Kieran works with biotech leadership teams to build the oversight systems that protect timelines, budgets, and data integrity. Learn more at seuss.plus.
