Kristen N Linney
Founder & Principal Consultant
With over 27 years of experience leading global clinical research across academic, government, and CRO settings, Kristen brings a deep commitment to advancing clinical development through innovation, collaboration, and operational excellence. Her career spans leadership in decentralized trials, large-scale NIH-funded initiatives, and strategic CRO operations—delivering impact across oncology, pediatrics, infectious disease, neurology, and genomics.
At Duke, Kristen led the design and launch of new research programs in epilepsy, genomics, and oncology, building the clinical trial infrastructure and operations from the ground up. She developed governance frameworks, SOPs, and monitoring models that enabled seamless study start-up and long-term scalability. Her leadership brought together investigators, institutional leaders, and operational teams to ensure regulatory readiness, data integrity, and efficient trial execution.
Key Differentiators
● Executive leadership, project management and regulatory expertise of Phase I-IV global trials with budgets exceeding $200M
● Track record leading and managing project teams across functional groups of 25+
● Published and recognized leader with collaborations across academia, CROs, pharma, and government sponsors
● Experience directing large programs with industry, government and cooperative group sponsors
● Extensive expertise in oncology, pediatrics, infectious disease, and rare diseases
● Track record in decentralized and hybrid trial execution with technology and vendor integration
● Proven success implementing AI-driven operational tools for compliance and resource management
● Licensed RN with 27 years’ experience across academia, CRO, and site operations
Select Publications:
● Ethical Challenges in Genotype Driven Recruitment
● Ipilimumab and Radiation in Patients with High-Risk Melanoma
