Clinical Operations Consulting
Guiding Biotech's
Most Critical Steps.
I step in as fractional VP/head of Clinical Operations for startup biotechs heading into their first clinical trials. I help you build the operational strategy, choose and manage vendors, CROs, and get the program ready to face regulators and boards with real numbers. After fifteen-plus years on both sides of the table, nine of them in a global CRO, I know where first trials break and how to catch them before they do.
"Most first-in-human trials fail not from the science but from operational missteps that were entirely preventable."
The unspoken reality of a first clinical trial is the immense pressure it puts on founders to manage a complex process they haven't run before. It isn't something you share with your board, and it isn't something you need to explain to me. When we work together, you don't have to project absolute certainty. You can just think out loud. I take the complexity of clinical operations and turn it into a precise sequence: what requires attention today, what can wait, and what to drop entirely.
How I Work With You
01
How I Work
There's no standard package here. What we do depends on what your biotech needs. Sometimes that's the whole operational picture: strategy, protocol design, CRO and FSP selection, vendor oversight, team building. Sometimes it's one hard problem, like how to design a first step to the first human study. We define the scope together at the start, and we adjust it when things change.
I work with a limited number of clients at any given time to ensure the depth of attention your biotech deserves.
Inquire About Consulting →02
Limited SeatsThe Program
Stepping into Phase 1 and Phase 2 clinical trials doesn't mean you have to learn clinical operations from scratch. This two-week program is structured as four 90-minute sessions specifically for founders, CEOs, COOs, CSOs, heads of research, and incubator leaders who need to understand the clinical trials landscape quickly. We'll look at how trials are executed, what you are legally and operationally obliged to do as a Sponsor, and exactly where you can optimize your budget to save money. It’s an ideal primer if you are thinking to hire an internal clinical ops lead or partner with a CRO, giving you absolute clarity on what you are buying and what your options are beyond the standard full-service package.
Learn More About the Workshop →The Stakes
Nine out of ten
clinical trials fail.
Here is where I help:
- Defining a clear, executable clinical operations strategy aligned with company goals
- Stress-testing protocol design for feasibility, patient access, and operational risk
- Building realistic timelines, budgets, and vendor strategies that hold under pressure
- Establishing fit-for-purpose operational frameworks without unnecessary complexity
- Supporting vendor selection, oversight, and performance management
- Identifying risks early and guiding course correction before they become costly
- Providing executive-level clarity through structured updates and recommendations
- Acting as a consistent strategic partner across study startup and execution
"The biotechs that succeed are not always the ones with the best science. They are the ones who built the right operational foundation before they ever enrolled a patient."
The program — The Anatomy of the Clinical Trial
From Zero to Trial-Ready
in Four Sessions.
In four sessions you build a complete understanding of what you got yourself into when you decided to become a clinical-stage company. I will help you think through the operating reality of your own Phase 1 or 2 trial — the sponsor obligations, the vendors, the sites, the budget, and the inspectors.
Every session comes with working documents forming the working skeleton of a Phase 1 or 2 study. You will leave with the architecture to run your trial, instead of a blank page and a CRO proposal, you cannot judge. If your first trial is on the horizon, do yourself a solid and learn what it means to plan and run it.
The Workshop is currently being prepared. Join the waiting list to be notified when enrollment opens.
Join the Waiting List"I work with a small number of clients at any given time. The depth of attention your program deserves cannot be delivered at scale."
Ready to talk
about your program?
A 30-minute conversation is often enough to understand whether we're the right fit for each other.