Job Title:
Head of Clinical Development
Department:
Clinical Development
Location:
Poleg, Netanya. Israel
About Caps Medical

CAPS Medical has developed a highly selective and minimally invasive Non-thermal Atmospheric Plasma (NTAP) device able to painlessly treat a wide range of solid tumors without impacting surrounding tissue.

Objective:

Working at CAPS Medical will enable you to grow your career and join a team of talented people, committed to making a difference in the way cancer is treated. CAPS medical is seeking a talented Head of clinical Development with a focus on research and development of complex multidisciplinary devices, to join our growing team and participate in the development of Non Thermal Plasma technology, with role growth opportunities. In this role you will take part in development and execution of the company’s clinical development strategy and goals . To research and define next clinical applications support and involvement in R&D effort alongside the clinical team.

Main Responsibilities:

o    Ownership of User Requirements, including  the gathering, analysis, and presentation of market input and VOC

o    Define clinical needs, risk analysis and product requirements, while driving cross functional stakeholder alignment 

o    Develop the business justification for new products/enhancements 

o    Foster key relationships with KOLs to gather information, identify needs, and assess opportunities 

o    Build and educate cross functional teams on clinical workflow 

o    Take central role  in building  multigeneration product portfolio by identifying and analyzing addressable clinical indications, clinical and reimbursement cost structure, competitive landscape

o    Develop new clinical indications  

o    Collaborate with key physicians on clinical procedure development 

o    Ownership and submission of governmental and institutional grant programs

o    Ownership of user workflow Implementation UX/UI

o    Support regulatory and clinical activities including design validations and usability activities

o    Support product launches to collect and analyze early field feedback 

o    Participate in development and validation of product package and labeling throughout PLC –from requirement through managing execution and testing.

o    Development of Pre-clinical infrastructure 

o    Develop and implement test models and test methods for clinically relevant product evaluations, in vitro, in vivo, anatomical models and simulators

o    Develop the strategy for clinical studies to meet business goals and objectives. Collaborate with internal stakeholders and KOLs to develop and review study concepts, driving identified initiatives 

o    Act as a key strategic partner to Regulatory Affairs to support regulatory approval process 

Requirements:

o    PhD / MSC in life sciences/ MD/ Engineering.

o    At least 5 years’ experience in the medical device industry.

o    Ability to operateaccording to applicable regulations and standards, such as QMS, GCP, etc.

o   Technical/ Clinical documents writing

o    Proven hands on experience in the conduct of clinical development, client facing product development.

o   Proven hands on experience in design and execution of In vitro and In Vivo studies

o    Excellent self learning capability

o    High interpersonal skills

o    Excellent team work skills

o    Strategic thinking

o    Fluent English.

To apply, please submit your CV to: