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Heartflow

Director, Clinical Operations

Heartflow, San Francisco, California, United States, 94199

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Overview

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Note:

Heartflow is a publicly traded company (HTFL) with recognition for healthcare innovation and a global footprint of use in the US, UK, Europe, Japan and Canada, supporting adoption by medical societies and having been used for more than 400,000 patients worldwide. Responsibilities

Lead a team of clinical trial professionals Participate in clinical research activities including management of clinical study sites, study documentation, and project management tasks Develop clinical trial and program timelines, enrollment projections, documents, and instructional materials to support trial execution (including project communication, monitoring, recruitment, risk mitigation, and contingency plans) Conduct study start-up activities including protocols, informed consent forms, source document worksheets, and training materials Review site regulatory documents (informed consents, IRB approvals, research agreements/budgets) to ensure compliance with study requirements and GCPs Maintain relationships with investigators, study coordinators, and vendors including core labs and CROs Manage vendor and CRO activities and track project deliverables to stay within timeline and budget Participate in and lead process improvement activities within the department and cross-functionally Manage clinical trial budgets and accounting Perform other duties as necessary Some travel may be required Qualifications

Ability to work in a smaller team environment with an all-hands-on-deck attitude Ability to manage multiple tasks with shifting priorities Exceptional attention to detail, accuracy, and quality Strong ability to prioritize multiple projects Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations Excellent written and oral English communication skills Proficiency in Microsoft Office (Word, Excel, PowerPoint) and Google Workspace (Sheets, Slides) Bachelor’s degree in science or health-related field; 10+ years of relevant experience; experience managing a team and a CRO Experience in cardiovascular medical device clinical research is a plus Compensation and Additional Details

A reasonable estimate of the base salary compensation range is $210,000 to $260,000, plus cash bonus and equity. Equal Opportunity Employer

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

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