BIO
Roxana Robini
Senior Medical Director, Head, Medical Sciences
Dr. Roxana Robini, MD is a qualified physician who specializes in Family Medicine and has several years of broad clinical experience gained in Internal Medicine, Pediatrics, Gynecology & Obstetrics as well as General Surgery.
Work Experience
Industry experience involves various aspects (medical monitoring, drug safety, DM) and phases (II-IV) of clinical drug development, working on more than 40 clinical research projects in various therapeutic areas since 1993 (cardiology, neurology, ophtalmology, psychiatry, HIV), with a focus on oncology and pneumology.
Dr. Robini has been with Parexel, a Contract Research Organization for over 15 years. Her clinical trial experience has included all phases (Phases I-IV) of clinical and post-marketing development as well as Expanded Access and Named Patient Programs.
With more than ten (10) years as Medical Monitor (MM), Dr. Robini has been responsible for the overall coordination of the medical monitoring activities and safety monitoring tasks delegated to PAREXEL and for providing scientific and technical leadership to the project team. In her role, she is identified as the primary contact by the sites for all questions concerning the medical aspects of the protocol, patients’ eligibility criteria, study drug administration as well as safety issues (review of CRF data, labs, narratives) in close collaboration with the medical officer of the sponsor.
Following (5) years as Drug Safety Physician and Pharmacovigilance Manager, Dr. Robini through her extensive exposure to clinical trials management and team-oriented approach,
is fully appreciative of GCP standards, adherence to protocol design, the importance of safety monitoring and maintaining the integrity of patient data collected during clinical trials.
Dr. Robini currently provides guidance related to the execution of various clinical studies in oncology with a total of 8 trials in indications such as breast, lung, ovarian and renal cancers as well in pneumology trials (COPD-16 000 patients, Bronchiectasis -1000pts).