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.
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.
The Director, Clinical Operations is responsible for the oversight and management of all clinical operational activities. The Director will interact well with the HeartFlow Clinical Research staff and collaborate effectively with HeartFlow onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure clinical studies meet or exceed timelines and maintain high quality standards. The Director will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture.
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
- Some travel required
- Ability to work in a smaller team environment with a willing, all hands on deck attitude
- Ability to manage multiple tasks and to be comfortable working in an environment with shifting priorities
- Incredible attention to detail, accuracy, and quality
- Able to effectively prioritize multiple projects
- Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
- Excellent written and oral English communication skills required
- Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel, and PowerPoint and in Google tools including Sheets and Slides
- Minimum of a bachelor’s degree in science or health related field
- Demonstrated 10+ years minimum relevant experience required
- Experience managing a team required
- Experience managing a CRO required
- Experience in cardiovascular medical device clinical research a plus
A reasonable estimate of the base salary compensation range is $210,000 to $260,000, cash bonus, and equity. #LI-Hybrid
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