Clinical Affairs Manager

DESCRIPTION

Responsible for the clinical aspects of medical device projects at all product life cycle, clinical affairs activities and special projects.

• Support of R&D process of medical devices development, including:

o Planning and execution of ex-vivo, in-vivo small and large animal studies

o Clinical requirements definition during early development

o Risk management process

o Management of KOL and medical advisory boards

• Planning and execution of clinical trials and different clinical activities (MPT, IST, LME) according to GCP and following company SOPs including:

o Contract negotiation, preparation of trial related documentation, IRB, study initiation visits, site monitoring and training, data collection, analysis and reporting, collaborating with physicians towards publication of study results,

• Full support to Regulatory / Clinical Strategy, including

o Writing and reviewing regulatory documents such as SOP, CER, validations etc

o Support product regulatory submission to FDA, cFDA and EMEA

o Preparation of clinical knowledge scientific documents

o Development and execution of post-marketing clinical plan

• Active participation in scientific meetings / lectures / congresses
• Support Business Units activities from the scientific/medical point of view in strategic thinking, planning and execution including:

o Supporting the writing and review of marketing materials and white papers

o Contact person in any communication with leading physicians, KOLs and consultants

o Literature search and providing clinical publication supporting materials

• Ability and willingness to travel abroad (10%-20%)

REQUIREMENTS

• MD/PhD (preferable) or Master’s degree in life sciences\medicine\biomedical engineering
• Experience with digital health and AI for healthcare (preferable)
• Experience of at least 1-2 years in clinical research in and outside of Israel (Must)
• Experience of at least 1-2 years in medical device industry(preferable)
• Regulatory/Clinical documents writing
• Ability to independently lead clinical research
• High interpersonal skills
• Fluent in English spoken and written
• Excellent teamwork skills
• Strategic thinking
• Presentation skills
• Leadership skills