Overview

Learn more about the general tasks related to this opportunity below, as well as required skills. HeartFlow is a medical technology company advancing the diagnosis and management of coronary artery disease, using cutting-edge technology. 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 offers AI-driven, non-invasive solutions across the CCTA pathway to help clinicians identify stenoses, assess coronary blood flow, and characterize and quantify coronary atherosclerosis. Our pipeline of products is growing and so is our team.

HeartFlow is a publicly traded company (HTFL) with recognition for healthcare innovation and a global footprint in the US, UK, Europe, Japan and Canada, used for more than 400,000 patients worldwide.

Role summary The Director, Clinical Operations is responsible for the oversight and management of all clinical operational activities. The Director will collaborate with HeartFlow Clinical Research staff, onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure clinical studies meet or exceed timelines while maintaining high quality standards. The role requires demonstrated experience with clinical research study execution, strong organizational skills, attention to detail, and comfort operating in a fast-paced startup culture.

Responsibilities

Leads a 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 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

Skills and qualifications

Ability to work in a smaller team environment with an all-hands-on-deck attitude

Ability to manage multiple tasks and adapt to shifting priorities

Excellent attention to detail, accuracy, and quality

Strong prioritization of 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 tools (Word, Excel, PowerPoint) and Google tools (Sheets, Slides)

Educational requirements and work experience

Minimum of a bachelor’s degree in science or health-related field

Demonstrated 10+ years of relevant experience

Experience managing a team

Experience managing a CRO

Experience in cardiovascular medical device clinical research is a plus

A reasonable estimate of the base salary compensation range is $210,000 to $260,000, with 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. This policy applies to every aspect of employment at HeartFlow, including recruitment, hiring, training, relocation, promotion, and termination.

Positions posted for HeartFlow are not intended for or open to third party recruiters/agencies. Submission of unsolicited resumes will be considered free referrals.

HeartFlow has become aware of a fraud where unknown entities are posing as HeartFlow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information, please verify: A) all legitimate HeartFlow recruiter email addresses end with "@heartflow.com" and B) the position described is on our careers site at www.heartflow.com/about/careers/.

#J-18808-Ljbffr