Clinical Affairs Manager

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 also in Tel-Aviv) with a strong business performance worldwide.

Lumenis is looking for a Clinical Manager for the Aesthetics Business, 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 product portfolio including: pre-clinical testing, clinical input to regulatory submissions and registrations, 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 value and benefits of the solutions.

Key responsibilities:

· Lead post-market clinical activities for evidence generation and training: clinical trials and different clinical activities (sponsored, IIT, grants) according to GCP(ISO-14155/MDR/CFR) and following company SOPs, protocol development, training development and more

· 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

· Support R&D clinical activities for assigned products including: bench-top, pre-clinical ex-vivo and in-vivo, validation, usability and more

· Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product, marketing and regional teams

REQUIREMENTS

Requirement:

· PhD/MD (preferable) or Master’s degree in life sciences- required

· 2+ years clinical research experience in industry or academic environment (hands-on), preferably including leading clinical studies or joint research

· A passion for science and data as a basis for developing outstanding clinical solutions

· Outstanding interpersonal skills including developing relationships inside and outside of the organization

· Excellent project management/execution and organizational skills

· Fluent English (written and spoken)

· Travel (15%); Global