Operational Depth.
Strategic Reach.
Equally comfortable discussing study execution with operational teams or working with senior leadership on governance strategy and organizational effectiveness - and that combination is what Florentix brings to every engagement.
From delivering studies to enabling organizations
For most of my career, I led global Phase I-III clinical trials, building and leading international teams while navigating the operational complexity of clinical development.
As the industry evolved, so did my role. I moved beyond study execution into Vendor Governance and Operational Excellence, where my focus shifted from delivering individual studies to enabling organizations to perform at their best.
I designed governance frameworks, implemented operating models, optimized outsourcing strategies, and helped sponsors and external partners build more effective, transparent, and scalable ways of working. I also supported organizations in strengthening quality systems, improving inspection readiness, and ensuring that operational practices met regulatory expectations.
Today, I help pharmaceutical and biotech companies build stronger clinical development organizations. Drawing on more than 20 years of industry experience, I support clients in vendor governance, outsourcing strategy, operating model design, process optimization, and inspection readiness - helping them deliver clinical programs more efficiently, maintain regulatory confidence, and build sustainable operational capabilities.
- Clinical Development and Operations
- Vendor Strategy and Governance
- Global Program Delivery
- Operating Model Design
- Inspection Readiness
- Cross-Functional Leadership
How I Can Help
Two service tracks - shaped by 20 years at the intersection of strategic governance and hands-on trial delivery.
PARTNERSHIP AND GOVERNANCE
For pharma and biotech building or resetting CRO relationships
End-to-end accountability for the strategy, performance, and outcomes of your outsourced clinical model. I work at the intersection of asset leadership and strategic partners - driving alignment, resolving challenges, and ensuring delivery excellence across programs and regions.
- Outsourcing strategy and operating model design
- CRO and vendor governance frameworks
- Joint steering and portfolio-level oversight
- KPI development, performance monitoring, and escalation pathways
- Sponsor oversight and RBQM implementation (ICH E6(R3))
- Inspection readiness (FDA, EMA, MHRA, ANVISA)
- Partner capability assessment and feedback loops
CLINICAL OPERATIONS
For lean biotech needing experienced hands-on support
Direct operational support across the full trial lifecycle - from setup through close-out. I embed within your team to drive execution, lead cross-functional workstreams, and ensure studies run to time, quality, and budget.
- Study planning, start-up, and execution oversight
- Project and program management
- Team leadership and cross-functional coordination
- Issue management and risk mitigation
- TMF setup, eTMF oversight, and inspection readiness
- Process design and operational excellence initiatives
Career Track Record
20+ years across global pharma and agile biotech
Florentix Consulting - Zurich, Switzerland
Independent advisory in Clinical Operations, vendor governance, and outsourcing strategy.
Takeda Pharmaceuticals - Zurich
Led Business Operations and governance across global Clinical Development. Directed multidisciplinary team across vendor governance, eTMF/clinical systems, and inspection readiness. Designed operating models and KPI dashboards for portfolio oversight.
Takeda Pharmaceuticals - Zurich
Member of Clinical Operations Leadership Team. Global accountability for outsourced trial delivery, vendor governance, and ICH-GCP oversight.
Takeda Pharmaceuticals - Zurich
Built risk assessment frameworks and third-party oversight practices. Established KPI tracking and governance cadence.
Takeda Pharmaceuticals - Zurich
Led EU clinical operations. Interim Global Program Lead for a Bill and Melinda Gates Foundation-funded vaccine program.
Novartis Vaccines and Diagnostics - Siena / Cambridge MA
Global vaccine development programs, including international assignment in Cambridge, Massachusetts.
Eli Lilly and Company
Clinical trial execution in oncology. Progressed from site monitoring to regional oversight.
Insights
Perspectives on clinical operations, vendor governance, and the evolving landscape of global trial delivery.
- ICH E6(R3) and what the updated GCP guidelines mean for sponsor oversight
- Outsourcing operating models: how large pharma and emerging biotech are diverging
- Vendor governance as a strategic capability, not a compliance function
I write occasionally - on topics I find genuinely worth thinking about.
Let's Talk
Available for advisory mandates, interim roles, and project-based engagements. Based in Zurich - working internationally.