Job Title: Clinical Affairs Director
Reports To: Chief Medical Officer (CMO)
Location: Boston, MA
About Microbot Medical
Microbot Medical is a dynamic, publicly traded, global, medical robotic device startup company. The Company develops robotic devices in the interventional endovascular space that provides doctors and surgeons with new technological capabilities to improve a patient’s health, comfort, and quality of life. Our headquarters are in Boston, MA and our R&D is in Israel.
Objective
This position will play a pivotal role in building the Company’s position in the robotic surgery space. The Clinical Affairs Director will report directly to the Chief Medical Officer (CMO).
Main Responsibilities
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- Support the CMO with strategic planning for all clinical sites
- Executes global clinical affairs strategies, in collaboration with the CMO, regulatory affairs, sales & marketing and research & development
- Manage all clinical activities in the USA
- Identify and Build COE (Centers of Excellence)
- Develop relationship with PI’s {Primary Investigators}
- Create and execute objective end points for clinical studies
- Attend all studies, collect, and decipher data
- Share post market study results
- Provides training to clinical sites
- Prepares and manages clinical affairs budgets
- Prepares or assists with development of clinical documents submitted to regulatory authorities
- Develops clinical trial protocols and other study-related documentation
- Develops case report forms (CRFs) and oversees database building and management
- Manages vendors such as CRO’s, monitors, database administrators, biostatisticians, and other consultants
Qualifications & Requirements:
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- Requires a higher education in one or more of the following fields:
- Medical, Life sciences, or other scientific discipline
- 5 years’ experience in global clinical trials management
- Medical device experience – Early-stage startup experience- A Must
- Deep understanding of the market landscape for robotic surgery and preferably in interventional endovascular space– advantage
- Well versed in FDA regulations and standards, GCP guidelines and CE
- Excellent leadership, management, collaboration, and decision-making skills
- Outstanding written, verbal and presentation communication skills
- Highly organized and detail oriented, with solid analytical skills
- High caliber, dynamic personality that promotes a positive culture and self-starter who will take initiative
- Outstanding written/verbal communication skills
- Ability to travel 60% of the time
Pre-Application Form
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