Director, Clinical Operations

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 FFR CT 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 (RoadMapAnalysis), assess coronary blood flow (FFR CT 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.

Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide.

Job Responsibilities

• Leads team of clinical trial professionals
• Participates in clinical research activities including management of clinical study sites, management of study documentation, and completion of project management tasks
• Develops clinical trial and program timelines, enrollment projections, documents, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements / budgets) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators / investigational site research coordinators, and vendors including core labs and CROs
• Manage vendor and CRO activities, and track internal and external (CRO / vendor) project deliverables to ensure they remain within the timeline and budget
• Participates in and leads process improvement activities within the department and cross-functionally
• Manage clinical trial budgets and accounting
• Perform other duties, as necessary

Skills Needed

Educational Requirements & Work Experience

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

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.

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