/CLINICAL MANAGER

CLINICAL MANAGER

United Statesusvia direct
// Job Type
Full Time
// Salary
Not disclosed
// Posted
4 months ago

About the Role

About the role:       Lumenis is a fast-growing, global leader in energy-based solutions for Aesthetics and Eye-Care. We are based in Yokneam, Israel (with offices in Tel-Aviv) with a strong business performance worldwide.We are looking for a Clinical Manager for the Aesthetics Business Unit, which includes a broad portfolio of leading solutions in the market as well as an exciting innovation pipeline. The Clinical Manager will be responsible for pre and post-market activities for the assigned platform including: clinical requirements guiding design input, pre-clinical testing, clinical input to regulatory submissions, market conditioning for new solutions, post-market evidence generation and KOL development. The individual will serve as a major pillar in building relationships with global KOLs and demonstrating the clinical value and benefits of the solutions.Key responsibilities:Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation.Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product, marketing, and regional teamsCoordinate internal cross-functional teams, as well as external clinical research associates, data managers, and biostatisticiansOversee the execution of clinical studies, ensuring adherence to protocols and regulatory requirementsLead the clinical input and support for key regulatory submissions and processes: regulatory submission clinical input, clinical validations, CER, CDP, CEP and moreSupport marketing/commercial activities from the scientific/medical point of view: review and input to marketing collateral, develop white papers, active participation in scientific meetings and moreCommunicate project status to stakeholders and provide updates on milestones and deliverablesIdentify potential risks and implement mitigation strategies to ensure project success.

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