With more than 14 years of clinical research experience, Dr. Kristen Ballesteros is Director of Strategic Feasibility for Hematology/Oncology at PPD, part of Thermo Fisher Scientific, where she develops global feasibility, site identification, and operational strategies for oncology programs.
Dr. Ballesteros brings a unique 360-degree perspective to site selection, combining CRO strategy with firsthand site-level business development experience. In her current role, she leads feasibility survey development, site identification, tiering and selection strategies; evaluates patient access, enrollment potential, site capabilities, and operational risks; and supports sponsor bid defenses and pharmaceutical partnerships. As a Feasibility SME for Early Development Oncology Services (EDOS), she evaluates established and emerging sites for complex early-phase oncology trials.
Prior to joining PPD, Dr. Ballesteros worked at the site level, developing business strategy, pursuing study opportunities, building sponsor and CRO relationships, and leading feasibility, contract and budget negotiations, and study start-up. This experience gives her practical insight into both how sites position themselves and how sponsors and CROs evaluate them.
Her work also includes supporting hematology/oncology and nontraditional sites seeking to expand into Cell & Gene Therapy, including patient-journey capabilities, operational readiness, infrastructure, and FACT accreditation. She is an advanced practitioner of generative AI in feasibility and operational strategy, applying AI alongside traditional data and expert judgment to strengthen patient-access analysis, trial landscaping, competitive intelligence, site and country assessment, and enrollment modeling.
Her expertise provides a practical lens into what makes a site truly study-ready—and what moves a site from consideration to a trusted, repeat partner.