דרושים Clinical Manager ביקנעם

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