Developing software tools for clinical data visualization, data management, statistical analysis and reporting.Providing comprehensive consulting services in clinical development to a diverse range of companies. Expertise in overseeing the full life cycle of clinical trials, from the initial design stage through to final submission to regulatory authorities.

Responsible for all aspects of clinical development in the company.Deeply involved in core management activities, including decision-making and risk assessment (company wise), Leading global clinical development, including road mapping, designing and executing global clinical trials. Building a large body of evidence from real-world data.Designed effective data systems and processes that increased efficiency and saved money to the company. Built a strong KOL network in the US and EU.Orchestrated multiple peer-reviewed publications, Developed and trained a panel of speakers in major conferences. Built and grew an agile clinical team with diverse skills.Drove R&D initiatives for pipeline products from research to pre-clinical proof of concept.Experienced in: FDA clinical & regulatory, EU market and post market activities, Real world use initiatives, Marketing (storytelling and science), Reimbursement in US and Germany, Scientific collaborations, pre-Clinical studies, R&D, QA (MDR/13485/14155), Sales in EU.

Participated in the management of global multicenter trials with neurostimulators in acute ischemic stroke. Managed patient recruitment, clinical quality, data management, and provided filed training with the use on an implantation navigation system. Interfaced with regulatory authorities such as the FDA, Health Canada, EU, and Taiwan ensuring compliance and smooth project progression.Experience in interfacing with relevant regulatory authorities including FDA, Health Canada, EU, European Non EU, TaiwanStrategic thinking and work with cross-functional teamsExperience and knowledge in the preparation of major and routine regulatory submissions Vigilance program leadership

International multicenter trial Management including: Country and site feasibility assessment, Patient recruitment management, Clinical Quality and data management, Training clinical teams, Agreements negotiation, Regulatory submissions.

Managed, planned, and executed phase I and III clinical trials in Oncology, Dermatology and Stroke

Managed and monitored phase I-III clinical trials in Oncology and Cardiovascular diseases.