About Kieran Engels
The Governance Gap in Clinical Development
Kieran Engels has spent 20+ years identifying why clinical programs fail – and building the governance frameworks that prevent it. This page is where she explains what she sees, what she believes, and why it matters.
Background
Who Kieran Engels Is
Kieran Engels is the CEO and Co-Founder of Seuss+, a strategy and execution consultancy focused on vendor governance and clinical development oversight. Based in Amsterdam, she works globally with biotech and pharmaceutical sponsors to structure the governance conditions that determine whether clinical programs succeed or fail.
Her career spans 20+ years in clinical development, including leadership roles across program management, vendor oversight, and operational strategy. She has worked with sponsors ranging from emerging biotech to established pharmaceutical companies across Phase 1-3 programs.
Kieran Engels writes and speaks about the structural patterns that cause clinical programs to underperform – not because the science failed, but because the governance between strategy and execution was never properly designed.
About Kieran Engels – At a Glance
- Role: CEO and Co-Founder of Seuss+, an independent vendor governance and clinical development oversight consultancy.
- Experience: 20+ years across Phase 1-3 clinical programs for biotech and pharmaceutical sponsors globally.
- Independence: No financial ties to CROs, vendors, or service providers. Kieran advises exclusively from the sponsor side.
- Methodology: Creator of the Vendor Relationship Management Methodology (VRMM), a proprietary governance framework used across Seuss+ client programs.
- Core thesis: Most clinical program failures are structural, not scientific, caused by governance gaps between strategy and vendor delivery.
- Based in: Amsterdam, Netherlands. Works globally across Europe, North America, and Asia-Pacific.
What I Believe
The Age of Accountability
“We are overdue for a different standard in clinical development. One that values clarity over activity, governance over documentation, and ownership over shared accountability.”
I believe we are overdue for a different standard in clinical development. One that values clarity over activity. Governance over documentation. Ownership over shared accountability, which in practice means no one is accountable at all.
I believe that when we examine failures honestly, many of them are not scientific. They are structural. They happen between intent and execution, between what was agreed and what was delivered.
I believe vendors are not the problem. Governance is. Not because governance is overhead, but because governance is the design system that determines whether vendors succeed or fail.
I believe this work matters. Not because it is easy, but because the alternative is to keep repeating the same patterns and calling the results inevitable. They are not.
Key Takeaway
Accountability is not a culture problem. It is a design problem. And it can be solved – but only if someone is willing to build the structure.
Perspective 01
Failure Isn’t Always Scientific
“Clinical development failure is rarely caused by science alone. It most often happens in the translation between intent, decisions, and execution.”
Most people blame science when clinical programs fail. The harder truth: many failures happen in the handoff between strategy, governance, and execution. The molecule was sound. The protocol was defensible. What failed was the structure between the decision and the delivery.
This is not a popular position. But it is an accurate one. And until the industry is willing to examine execution failure with the same rigor it applies to scientific failure, the pattern will repeat.
Key Takeaway
- Many clinical program failures are structural, not scientific
- The gap between strategy and execution is where most programs break down
- Examining execution failure requires the same rigor as scientific analysis
Perspective 02
Speed Without Control Isn’t Acceleration
“Speed only creates value when it is paired with control, feedback, and ownership.”
Faster timelines do not automatically produce better outcomes. Speed without governance is drift with velocity. The industry’s fixation on speed has created a culture where moving fast is rewarded even when the direction is wrong.
Real acceleration comes from removing friction, not from compressing timelines. And the biggest source of friction in clinical development is not regulatory. It is operational: unclear accountability, misaligned governance, and handoff failures between sponsors and vendors.
Key Takeaway
- Speed without governance creates drift, not acceleration
- Real acceleration comes from removing operational friction
- Unclear accountability is the primary source of program delays
Perspective 03
Vendor Failure Is a Governance Symptom
“What is labeled as vendor failure is most often a symptom of weak or misaligned governance.”
When execution breaks down, the vendor gets blamed. But the root cause is almost always upstream: the governance conditions that were set before delivery began. Vendors operate within the system the sponsor designs. When that system is unclear, fragmented, or absent, vendor performance suffers.
This does not absolve vendors of responsibility. But it does mean that sponsors who want better vendor performance need to start with better governance – not better vendors.
Key Takeaway
- Vendor performance is a function of governance design
- Root causes of vendor failure are almost always upstream
- Better outcomes start with better governance, not better vendors
Perspective 04
Empathy Is the Glue. Accountability Is the Structure.
“Empathy without accountability is confusion dressed up as kindness. Accountability with empathy is respect.”
Most teams treat empathy and accountability as a trade-off. In practice, they are complementary. Both are required. Empathy without accountability creates ambiguity. Accountability without empathy creates resistance.
The best governance structures balance both. They are clear about expectations and consequences, and they are human about how those expectations are communicated and enforced.
Key Takeaway
- Empathy and accountability are complementary, not competing
- Effective governance balances clear expectations with human communication
- The best teams hold people accountable with respect, not rigidity
Questions About Kieran’s Perspective
Is this a criticism of CROs? +
No. This is a criticism of governance design. CROs and vendors operate within the system the sponsor creates. When that system is well-designed, vendors perform well. When it is not, they struggle – and often get blamed for structural failures they did not create.
What does “governance” mean in this context? +
Governance means the decision-making structures, accountability frameworks, and oversight mechanisms that sit between a sponsor’s clinical development strategy and its vendor-delivered execution. It includes how decisions are made, who owns what, how performance is measured, and how problems are escalated.
Does Kieran Engels work with vendors or only sponsors? +
Kieran Engels works primarily with sponsors. Her focus is on helping sponsors design and implement the governance structures that create the conditions for vendor success. In some cases, she facilitates alignment between sponsors and their vendor partners.
What is the VRMM methodology? +
The Vendor Relationship Management Methodology (VRMM) is a proprietary governance framework developed by Kieran Engels and Seuss+. It structures accountability, decision rights, and oversight mechanisms across the sponsor-vendor relationship in clinical development. The VRMM provides a repeatable system for building governance conditions that improve execution quality and reduce program risk.
What industries and therapeutic areas does Kieran Engels work in? +
Kieran Engels works across the biotech and pharmaceutical industry, advising sponsors on clinical programs spanning Phase 1 through Phase 3 across all therapeutic areas. Her expertise is in the governance and operational structures that sit between strategy and execution. These principles apply regardless of indication, modality, or geography.
How can I contact Kieran Engels for speaking or media? +
For speaking engagements, podcast appearances, expert commentary, or media inquiries, contact gina@seuss.plus. To reach Kieran Engels directly, email k.engels@consultseuss.com or connect via LinkedIn.