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Biography
PERSONAL PROFILE
Profound Scientific and Medical background in Pre-Clinical (GLP/Non-GLP) and Clinical trials (Neurology,Psychiatry, Cardiology)- FIM, Feasibility, Single and Multi-center, PMS, RWE; Medical staff training; Full Clinical projects Management and Operation; Design and Writing all related documentation of Pre-Clinical / Clinical trials. Clinical Database Management. IRB and MOH submissions and Vendor negotiations contracts.
WORK EXPERIENCE
Jun 2016-current: Clinical development Director, Keystone Heart, Caesarea.
• Plan and execute various experiments in Pre-Clinical (GLP/non-GLP trials) trials in the Neurology and Cardiology domains (IL, US and China).
• Analysis of Clinical and Pre -Clinical data (CT, Angio, MRI) in cooperation with R&D/Clinical/CRO teams.
• Provide support in FDA and CE submission processes.
• Provide Medical Support to achieve the objectives and the strategies of the company in international Business Development, Regulatory affairs, R&D, and Marketing.
• Creating and Executing Global (US, EU, and China) Clinical Education to the medical staff on the company
devices, clinical trials related documentation, device new developments and clinical SOPs.
• Creating and Executing Internal Medical/Clinical learning modules (in-house and remote) (Marketing & Sales Managers, Clinical Specialists, R&D Engineers, QA/RA Managers) on the company device and SOPs.
• Provide the necessary professional medical presence at client interactions, at regional scientific conferences, and in discussions with KOL.
• MDR (2017/745) experience with Clinical/Regulatory documents (CER, CEP, Literature review, Benefit risk analysis, PSUR, PMS plan/report, PMCF plan/report, Trend analysis, Benefit-Risk etc.).
• Write and review of Scientific Manuscripts and Abstracts.
• Medical Database Monitoring and Management.
• Provides guidance and direction for preparation/revision/writing of document templates, development of process, and preparation/revision of SOPs and guidance documents for the CA/QA/RA and R&D teams.
Apr 2015 – Jun 2016: Clinical Scientist, Imaging Clinical Applications (ICAP), Philips, Haifa
• Develop deep understanding of imaging procedures and radiology in the Neurology domain.
• Formulate concepts for innovative solution and methodologically to evaluate the ideas with end users (Radiologists, Neurologists).
• Provide Clinical insights to the clinical team creating device detailed requirements.
• Provide support to the Pre-Development and Development teams throughout the development lifecycle.
• Collaborate and maintain relationship with key customers to evaluate new concepts and prototypes.
• Identify required research\ initiate activities and perform Clinical Evaluations.
• Contribute to the enhancement of clinical understanding within the R&D department.
Dec 2013 – Apr 2015: Clinical project manager, Keystone Heart, Caesarea.
• Managing investigational sites across EU and IL in regard to Neurocognitive evaluations, Neurological
examinations (NIHSS, mRS), and Imaging Data Acquisition (CT, Angio, and MRI).
• Verification and validation of Clinical Data entry.
• Clinical/Medical training of the medical staff (physicians (interventional cardiologists and surgeons), nurses, study coordinators, neuropsychologists, Cath lab techs) on the Company device, procedure protocols, neurocognitive evaluation assessments, device new developments, clinical updates, and clinical studies workflow.
• Overseeing and scientific support of data analysis activities in cooperation with Biostatisticians.
June 2012-June 2013: Neuroscientist, and Analysis team leader, R&D, Elminda, Herzliya.
• Prioritization and conflict resolution of company projects within the analysis team.
• Overseeing and scientific support of analysis activities within research projects.
• Analysis of electrophysiological data in cooperation with software/biomedical engineers.
• Improve team members proficiency (statistics, neuroscience, clinical related issues).
2007-2012: Clinical scientist, Wohl institute for brain imaging, Sourasky Medical Center, Tel-Aviv.
• Writing and submitting Clinical study documents to EC.
• Designing and writing Clinical Research Protocols and related documentations.
• Conducting Computerized Cognitive assessments (Neurotrax, Midstream, CogniFit and BRC).
• Simultaneous fMRI-EEG Recording and Data Analysis in cooperation with software/biomedical engineers.
• Writing and submitting of grant applications for international research funds.
• Writing Abstracts and Manuscripts for publication or presentation in national and international scientific meetings.
EDUCATION
2007-2013: PhD in medical science, neuroscience field of research.
Academic average: 98
Tel Aviv University, Sackler Faculty of Medicine, Department of Physiology and Pharmacology.
Thesis: "Neural correlates of cognitive fatigue in Multiple Sclerosis: a combined fMRI/ERP approach".
Supervisor: Prof. Talma Hendler. Co-supervisors: Prof. Ariel Miller, Prof