Breakwater Biopharma Partners
Fractional clinical operations leadership for Series A and B sponsors moving toward a registrational program — CRO oversight, site activation, TMF integrity, inspection readiness — without adding headcount you'll have to defend at the next raise.
Left of the line: vendor drift, enrollment variance, TMF debt.
Right of it: a study your board and an inspector can both follow.
Why sponsors call
Rarely framed as an operations problem at first. Usually framed as a timeline problem, a CRO problem, or a board problem.
The CRO is running the study, and no one on our side can tell us whether it's running well.
Oversight exists on paper. What's missing is the small set of metrics, meeting structures, and escalation paths that turn a monthly status deck into an early warning.
Sites are activated, but enrollment keeps sliding a month at a time.
Activation and enrollment are different problems with different fixes. Treating them as one is why the forecast keeps moving without anyone being able to say why.
The next study is registrational, and the way we work today won't hold.
What carries a Phase 1 through — good people improvising fast — becomes the finding in a Phase 3 inspection. The gap is usually documentation and decision traceability, not effort.
Where we work
Breakwater works inside your team — in your systems, in your meetings, accountable for outcomes rather than deliverables alone.
Leadership
Acting head of clinical operations for sponsors who need the judgment of a VP before they can justify the salary of one.
Oversight
RFP and bid defense support, contract and change-order review, governance cadence, performance metrics, and recovery when a partnership has gone sideways.
Execution
Country and site strategy, startup critical path, feasibility that survives contact with reality, and enrollment forecasting you can defend to a board.
Cost
Study budget build, site payment structures, vendor scope comparison, invoice reconciliation, and monthly cost rollups that reconcile to accrual.
Quality
TMF health assessment and remediation, quality event handling, and readiness preparation well before an inspection is scheduled.
Scale
The SOPs, systems, roles, and vendor architecture a lean sponsor needs in place before a registrational program starts, not during it.
Fixed-scope engagement
A structured diagnostic of your clinical operations function against six domains, ending in a rated picture of where you stand and a sequenced plan for closing the gaps that matter before your next study starts.
Six domains assessed
Background
Breakwater is led by Deborah Goodman, who has spent roughly two decades in clinical operations across oncology and rare disease — inside sponsors and inside CROs, which is a useful thing to have been when a partnership needs repairing.
That work has spanned early-phase studies through registrational programs, and sites across North America, Europe, the United Kingdom, the Middle East, South Asia, and Africa. Small sponsors get the benefit of that range without carrying it as fixed cost.
Engagements are led personally. There is no bench of junior consultants behind this practice, which is deliberate — it caps how many clients Breakwater takes at once, and it means the person in your governance meeting is the person you hired.
How engagements work
Ongoing
A set number of days per month as your acting clinical operations lead. Best when you need continuity through a study rather than an answer to one question.
Diagnostic
Fixed scope, fixed fee, fixed timeline. Best when you know something needs to change before the next program and want it named precisely.
Defined
A specific piece of work with a clear end: a CRO selection, a TMF remediation, a budget rebuild, an inspection readiness push.
Get in touch
A first conversation is thirty minutes and costs nothing. If Breakwater isn't the right fit, you'll get a straight answer and, where possible, a better direction.