Nikoletta Kallinteris

Background

About Nikoletta Kallinteris

Clinical Research, Phase Immuno-Oncology Drug Development, Translational Medicine, Biologics, Vaccines, Study Design and Start up, Protocol Development, Program Management, Clinical Operations, Translational Medicine Operations, Biomarkers Assays Development and Standardization Cross-functional leadership representing the development team across project teams. Scientific presentations at conferences, investigator and scientific advisory board meetings Immuno-oncology drug development (Pre-IND to phase program management, study design/start up, protocol development, correlative studies design and execution; data listings & patients' profiles review, analysis and interpretation Author and manage team review the clinical sections of regulatory documents such as protocols and amendments, IND sections, CSRs/appendices, IB, annual reports Oversight of activities related to data generation and validation including the clinical data review plan (CDRP), CRF, ICF, queries resolution in cross-functional collaboration with data management, biometrics, and clinical operations Strong expertise in translational medicine utilizing biomarker-driven correlative studies to inform faster data driven go/no go decisions Execution of biomarker and translational strategies for clinical development of biologics from early to late stages. Oversight of CROs, vendors and specialty labs Guide specialty labs for the selection of innovative clinical assays and biomarker panels for execution of secondary/exploratory endpoints Provide guidance to the translational informatics and biometrics teams for clinical and translational data analysis, correlative analyses merging clinical with translational data Certified Clinical Research Professional (CCRP) in 2018, 2015, 2012 Patents inventor or co-inventor. 19+ peer-reviewed publications with leading or co- authorship (NIH & SBIRs grants funded). 30+ abstracts, posters, and presentations at SITC, ASCO, ESMO & AACR