Science Meets Strategy
I help life science companies turn scientific breakthroughs into successful clinical programs—combining regulatory expertise, operational excellence, and strategic clarity.
Driving Clinical Innovation with Strategic Precision
Independent clinical research strategist with 13+ years of experience bridging science, quality, and regulatory excellence for Pharma, Biotech & MedTech.
With a background in life sciences and over 13 years of international experience in Pharma, Biotech, and MedTech, I act as an independent clinical research strategist who bridges scientific innovation with operational and regulatory excellence.
Building on my academic foundation and early-stage research in molecular biology and medical sciences, I have evolved into a cross-functional expert—combining scientific precision with hands-on business sharpness, also in entrepreneurial activities.
I facilitate high-impact clinical development by aligning science, quality, and strategic execution in dynamic environments. Whether supporting strategic clinical programs, optimizing study delivery, or translating regulatory pathways (e.g., ICH E6(R3), CTR, MDR) into lean execution models, I bring clarity and drive to projects with a high level of commitment.
This integrative approach enables me to support biotech innovators, medtech challengers, and established pharma players alike—across early-phase trials, pivotal studies, and strategic transitions between science, compliance, and access.
ICH E6(R3) is not a buzzword – it’s the framework for a new era of thoughtful, risk-proportionate, and patient-focused research.
Strategy & Delivery
“From early planning to critical pivots —move forward with clarity and confidence”
Whether you’re entering the next clinical development phase, navigating operational bottlenecks, or managing increasing regulatory complexity- bridge gaps and accelerate outcomes where complexity meets execution
Strategic Clinical Oversigh
Interim roles, trial leadership, turnaround management
Regulatory & Start-Up Excellence
Site identification, ethics submissions, alignment with CTR and MDR requirements
GCP & Quality Guidance
Audit support, protocol optimization, aligned with ICH E6(R3) and evolving EU regulations frameworks
Lean & Agile Trial Execution
Smart vendor coordination, risk-based delivery, SOP integration
Translational Positioning
Bridging clinical development with Medical Affairs and value-based access strategy
REA. WORKS provides partnership-based expertise – scalable, transparent, and tailored.
Why it matters
The research environment is shifting. Standardized outsourcing approaches have reached their limits in terms of flexibility, continuity, and stakeholder alignment. As development timelines tighten and expectations grow, a more integrated and quality-driven model is needed.
Empowering scientific leaders and companies to lead with clarity and deliver with confidence through:
1:1, On-demand, embedded expertise – not layered hierarchies
Methods aligned with long-term goals and sustainability principles
Consistent collaboration across scientific, regulatory, and operational domains
Solutions designed for continuity, not just transactions
FOCuS AREAS
“With a background as CRA, Clinical Project Manager, Founder and Strategic Advisor, I collaborate across roles and responsibilities – guided not by titles, but by outcomes. As an independent expert, I combine operational depth with a resilient entrepreneurial perspective to contribute where real impact is needed”
EXPERTISES
Therapeutic Expertise
Oncology, Neurology, Cardiovascular – with a deep understanding of indication-specific trial complexity and patient-centric endpoints
Clinical Development Stages
Early-phase (FIH, Phase I/IIa), adaptive designs, pivotal Phase IIb/III trials – including transitional support towards market readiness.
Geographic Scope
Globally with EU operational footprint, proven ability to coordinate and align with global teams
Cross-Functional Collaboration and Excellence
Seamless interface between Clinical Operations, Medical Affairs, Regulatory Affairs, and Market Access to ensure strategic alignment across development phases
Special Capabilities
Embedded expertise for time-critical trial rescue, quality remediation (GCP/ICH E6 R3), and lean execution strategies tailored to required needs. Centralized & Decentralized study and project approach
LET`S TALK
If you’re looking for a partner who combines strategic thinking with operational clarity – I’d be happy to connect.
WRITE
kim@rea.works
