Director Clinical Affairs

AccuLine is a medical device startup founded in early 2022 with a vision to save the lives of millions of people worldwide by preventing the next heart attack.

AccuLine is developing CORA - a fast, accurate, non-invasive, inexpensive, and user-friendly examination for the early detection of coronary artery disease, aiming to replace inaccurate stress test exams. Our technology is based on the discovery of two bio signals in the heart’s electrical activity and deep learning analysis of several vital signs during a 4-minute exam. The exam can be performed easily by any medical staff personnel in any setting, and the results are provided immediately.

AccuLine received two grants from the Israeli Innovation Authority, and among our shareholders are eHealth Ventures, Maccabi Healthcare Services, and Mayo Clinic.  

This is a unique opportunity to join the company at its early stages as one of its first employees, where you will be entrusted with the crucial task and the resources needed to shape the creation of a game-changing product with the potential to positively impact millions of lives.

Position Overview

The Clinical Affairs Director will play a pivotal role in driving the clinical strategy and execution of clinical trials for our CORA system. This individual will be responsible for leading all aspects of clinical affairs, including regulatory submissions, study design, site management, data collection, analysis, and publication.

The Clinical Affairs Director will collaborate closely with cross-functional teams to ensure the successful planning and implementation of clinical programs in accordance with regulatory requirements and company objectives.

Job description

·       Develop and implement clinical trial strategies in alignment with business goals 

·       Lead the planning, execution, and management of clinical studies

·       Protocol development, site selection and management, and investigator meetings

·       Manage relationships with CROs in Israel and US

·       Literature review

·       KOL management

·       Close contacts with potential customers to drive clinical insights 

·       Scientific writing and publication

·       Taking the lead role in managing regulatory submissions  

·       Writing grant requests and managing grant reports

·       Clinical content creation

·       Meetings with scientific committees

Job Requirements

·       Advanced academic degree, preferably PhD or MD

·       At least 3 years' experience in a similar role, preferably in a startup company

·       Medical Device industry experience - must 

·       Experience in clinical study design including IRB writing and biostatistics

·       Expertise in regulatory requirements (FDA, EU MDR) and regulatory submissions.

·       Knowledge & experience in complying to regulatory requirements

·       Ability to work collaboratively with a "can-do" attitude in a small company environment 

·       A visionary, yet organized and detailed oriented 

·       Hands on personality - willing to support various activities of the company

·       Ability to work in a fast-paced, entrepreneurial environment with minimal supervision

·       Ability to effectively manage cross-functional teams and external stakeholders.

·       Excellent verbal and written communication skills.

·       Presentation skills 

·       Strong computer skills, mainly Excel and PowerPoint