Clinical Manager

Description:

Lumenis is a global leader in energy-based solutions for Aesthetics and Eye Care. Headquartered in Yokneam, Israel, with offices in Tel Aviv, Lumenis has a strong global presence and business performance worldwide.

We are looking for a Clinical Manager to join our Aesthetics Business Unit, which includes a broad portfolio of leading market solutions as well as an exciting innovation pipeline.

The Clinical Manager will be responsible for pre-market and post-market clinical activities for the assigned platform, including defining clinical requirements to guide design input, leading pre-clinical validation planning and execution, providing clinical input to regulatory submissions, supporting market conditioning for new solutions, generating post-market clinical evidence, and developing relationships with key opinion leaders.

This role is a key pillar in demonstrating the clinical value, safety, performance, and benefits of Lumenis solutions, while strengthening relationships with global KOLs, clinical investigators, and cross-functional stakeholders.

Key responsibilities:

• Develop and manage end-to-end clinical project plans, timelines, and budgets, from early clinical research and pre-clinical validation through clinical trials, publications, user guidelines, and post-market evidence generation.
• Drive cross-functional collaboration across multiple interfaces and business units.
• Conduct deep clinical and scientific assessments, including review of the standard of care, clinical trends, mechanism of action, and emerging technologies, to support current and future product development and innovation.
• Define pre-clinical validation strategies and lead pre-clinical evaluation activities
• Lead the strategy, planning, and execution of clinical studies, ensuring adherence to study protocols, ethical requirements, Good Clinical Practice, regulatory requirements, timelines, and budgets.
• Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product management, marketing, regulatory affairs, quality assurance, clinical training, and regional commercial teams.
• Lead clinical input and support for key regulatory submissions and processes, including clinical rationales, clinical validations, clinical evaluation reports, and clinical development plans.
• Support marketing and commercial activities from a scientific and medical perspective, including review and input into marketing collateral, development of white papers, clinical summaries, presentations, training materials, and active participation in scientific meetings.
• Communicate project status to stakeholders, providing clear updates on milestones, deliverables, risks, mitigation plans, and key decisions.

• Bachelor's degree in life sciences, biomedical engineering, medical sciences, biotechnology, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in clinical project management within the medical device or pharmaceutical industry.
• Hands-on or demonstrated experience with pre-clinical testing, laboratory evaluations, pre-clinical study design, product performance evaluations, or validation activities for medical devices.
• Proven track record of managing clinical studies, validation activities, or cross-functional development projects simultaneously.
• Strong knowledge of Good Clinical Practice, clinical research regulations, and applicable medical device regulatory requirements.
• Familiarity with medical device quality systems, design control processes, risk management, and clinical evaluation documentation.
• Excellent organizational and leadership skills, with the ability to work under pressure, manage competing priorities, and drive projects to completion.
• Strong written and verbal communication skills, with the ability to present scientific and clinical information clearly to both technical and non-technical audiences.
• Fluent English, written and spoken.
• Willingness to travel globally, approximately 15%.