Jan Sixta

Background

About Jan Sixta

My background: MD, certification on internal medicine, 5 years of practice at hospital and outpatient clinic; professional record within Astra Zeneca, GSK, Novartis, Edwards Lifesciences, Medicem Institute; engagement in various medical areas, incl. vaccinology (clinical, medical and PhV roles) or medical devices (safety); experience from EU or global positions covering involvement in cross-functional teams; What I have learned: Medical expertise: working with scientific literature (Mendeley/EndNote user), EBM principles, critical reading and interpretation of scientific data; leading advisory boards and adjudication committees; presentation skills (certified speaker for Novartis Vaccines); Clinical expertise with safety and vigilance overlaps: good knowledge of GCP, management of the CTs phase I to handling individual AE reports (triage), writing aggregate reports (Clinical Evaluation Reports, Periodic Study Reports, PSURs), knowledge of the principles of signal detection; Clinical development expertise: development strategies for innovative products, involvement in designing CTs, contribution to writing study documents (protocols, CRFs, etc.), CTDs (mainly modules 2, 4 and 5) What is important to me: I care about medically reasonable content and ethical value of the work. I allways apretiate working with fair people. The more different perspectives and interdisciplinary overlaps, the better.