Clinical Manager
About The Position
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 teams
- Coordinate internal cross-functional teams, as well as external clinical research associates, data managers, and biostatisticians
- Oversee the execution of clinical studies, ensuring adherence to protocols and regulatory requirements
- Lead the clinical input and support for key regulatory submissions and processes: regulatory submission clinical input, clinical validations, CER, CDP, CEP and more
- Support 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 more
- Communicate project status to stakeholders and provide updates on milestones and deliverables
- Identify potential risks and implement mitigation strategies to ensure project success.
Requirements
- Bachelor's degree in life sciences or a related field; advanced degree preferred
- Minimum of 5 years of experience in clinical project management within the medical device or pharmaceutical industry
- Proven track record of managing multiple clinical trials simultaneously
- Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
- Excellent organizational and leadership skills, with the ability to work under pressure
- Effective communication skills, both written and verbal
- Experience with clinical trial management software and data analysis tools
- Fluent English (written and spoken)
- Travel (15%); Global
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