This article originally appeared as part of The Vendor Edge series on LinkedIn. This is an expanded and updated version for kieranengels.com.
Executional strength is not hiring better people or finding better vendors. It is building systems that allow good people and good vendors to perform. Many biotech organizations assume execution is a function of talent. Hire the best director. Bring in the most experienced CRO. Partner with the leading site network. Yet execution still stalls. The gap between talent and outcome is infrastructure. Kieran Engels works with leadership teams that have recruited exceptional people and partnered with respected vendors, yet timelines slip and costs overrun. The difference between organizations that execute well and those that don’t is not the talent at the table. It is the systems that structure how that talent works together. Executional strength means clear decision rights, defined accountability, regular feedback, and governance systems that surface problems early. These systems can be built. They are not mysterious. But they require intentional investment.
KEY TAKEAWAYS
Key Takeaways
- Executional strength is built through governance infrastructure, not through hiring talent or selecting vendors.
- Clear decision rights, defined accountability, and regular feedback are the three pillars of execution capacity.
- When accountability is distributed, no one owns outcomes. When it is singular, problems surface early and can be addressed while still small.
- Feedback cadence directly correlates with execution consistency. Weekly or daily feedback surfaces problems early. Annual feedback surfaces them too late.
- Building governance infrastructure requires leadership discipline and is often harder than changing vendors or people, but delivers more sustainable results.
The Challenge
The assumption in biotech is that execution is a talent problem. If you hire the right person, execution improves. If you find the right vendor, execution follows. But this misses the core issue. Talent and vendors are inputs. Systems are infrastructure.
Executional strength is what happens when systems allow inputs to perform. When decision rights are clear, talent does not waste time negotiating authority. When accountability is singular, vendors know exactly what they are responsible for and what escalation looks like. When feedback is regular, problems surface before they compound.
Let’s be clear. The organizations that execute well are not the ones with more talented people. They are the ones with more mature governance infrastructure.
Kieran Engels has worked with teams that included exceptional people. Directors with 15 years of experience. Vendors with pristine track records. Yet execution was inconsistent. When governance infrastructure was mapped, the pattern became clear. The talented people were spending energy on clarification, negotiation, and firefighting rather than on execution. The infrastructure was not in place to let talent work.
What changed? Not the people. The systems.
A clear example: decision authority. When is a decision made? By whom? Who has the final say? In immature organizations, this is ambiguous. A vendor wants to make a change. The sponsor leadership is unclear who has authority to approve. Debate happens. Time passes. The vendor waits. The timeline slips. This is not a talent problem. It is an infrastructure problem. The answer is a single decision matrix that says: this type of decision is made by this person, with this approval timeline, and here is how dissent is handled.
The Infrastructure
Another example: feedback cadence. How often does the vendor report? How often does the sponsor review? How often does escalation happen? In immature organizations, feedback is annual or quarterly. Problems fester. By the time they surface, they are expensive to fix. In mature organizations, feedback is weekly or daily. Problems are visible early. Adjustments can be made while they are still small.
The third example: accountability clarity. When something goes wrong, who is accountable? In immature organizations, accountability is distributed. The CRO says the sponsor should have been clearer. The sponsor says the CRO should have been more proactive. The site says they were following the protocol. No one owns the outcome. In mature organizations, accountability is singular. A person owns each outcome. That person is named. That person escalates early if they are at risk of missing the outcome.
These are not new concepts. They are not mysterious. They are infrastructure. And infrastructure is a choice. An organization either builds it or does not.
Seuss+ has worked with biotech leadership that faced persistent execution challenges. The first instinct is always to change vendors or change people. Sometimes that is necessary. But in most cases, the first work is governance. Define decision rights. Name accountability. Establish feedback cadence. Map escalation paths. Then execute.
What this requires from leadership is discipline. It is easier to assume a person or vendor is the problem. It is harder to admit that the organization does not have clear governance infrastructure. But organizations that make this admission and invest in building infrastructure see immediate improvement in execution consistency.
This is the work of building execution capacity. It is not about finding better vendors. It is about building the systems that let good vendors execute.
Executional Strength Assessment
| Dimension | Weak | Moderate | Strong |
| Decision Rights | Unclear who approves what. Debate happens on each decision. | Some clarity on authority. Occasional ambiguity in edge cases. | Explicit decision matrix. Single approver named for each decision type. |
| Accountability Clarity | Accountability distributed. Multiple people could own each outcome. | Some accountability. Unclear in some areas. | Single named owner for each outcome. Public escalation path. |
| Feedback Cadence | Annual or quarterly feedback. Problems surface too late. | Monthly feedback. Some visibility but delays remain. | Weekly or daily feedback. Problems visible within days. |
| Vendor Alignment | Vendor unclear on expectations. Surprises emerge during execution. | Vendor understands core requirements. Some disconnects on details. | Vendor and sponsor aligned on every requirement. Escalation defined. |
| Problem Escalation | Issues hide until crisis point. Late visibility. | Issues surface after impact. Some delay in response. | Issues visible early. Response immediate. Adjustments made while small. |
Executional strength is not hiring better people or finding better vendors. It is building systems that allow good people and good vendors to perform.
Key Industry Data
Phase II clinical trials average 75 protocol deviations, affecting nearly one third of enrolled patients. (Source: TransCelerate BioPharma)
Phase III trials average 119 protocol deviations per study, with oncology trials showing deviation rates affecting more than 40% of patients. (Source: TransCelerate BioPharma)
Electronic source data capture reduces protocol deviation rates by 54% compared to paper based systems. (Source: ACRP)
Organizations investing in structured quality training programs have achieved up to 194% improvement in cost avoidance. (Source: Healthcare quality benchmarks)
A single quality improvement initiative saved one health system $3.2 million in avoided penalties after training over 10,000 team members. (Source: Quality training ROI analysis)
Frequently Asked Questions
Experienced talent is necessary but not sufficient. Without governance infrastructure, experienced people spend energy on clarification and firefighting rather than execution. Clear decision rights, accountability, and feedback allow talent to focus on solving problems rather than establishing authority.
A decision matrix maps decision types to decision makers. For example: ‘Protocol clarifications are approved by the Medical Monitor within 5 days.’ ‘Vendor staffing changes require Sponsor approval within 10 days.’ ‘Budget adjustments under 10% are approved by Program Director. Above 10% require VP approval.’ Simple, explicit, and known to all parties.
Feedback should be regular enough to surface problems early. For most clinical programs, weekly feedback is sufficient. Some high-risk areas may need daily feedback. The key is that feedback happens on a known schedule, not when a crisis forces it. Consistency matters more than frequency.
Yes, though it is harder than building it at the start. Mid-program changes require retraining existing teams and shifting established patterns. But even mid-program, defining accountability and establishing feedback cadence will improve execution consistency for the remainder of the program.
The principles are the same. Clear decision rights, defined accountability, regular feedback. But the specifics vary by program complexity, team experience, and vendor relationships. A Phase 1 program needs less governance infrastructure than a pivotal Phase 3. The framework scales.
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.
