Offer summary

Qualifications:

Minimum of a bachelor's degree in a science or health-related field., At least 10 years of relevant experience in clinical research and team management., Experience managing a Contract Research Organization (CRO) is required., Knowledge of ICH Guidelines and US FDA regulations is essential..

Key responsabilities:

Lead a team of clinical trial professionals and oversee clinical operational activities.

Manage clinical study sites, documentation, and project management tasks.

Develop clinical trial timelines and ensure compliance with study requirements.

Maintain relationships with investigators and manage vendor activities to meet project deliverables.

Job description

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_CTAnalysis—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 (FFR_CTAnalysis), 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 VC-backed company 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. #LI-IB1; #LI-Remote

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, as well as 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) to ensure compliance with study requirements and GCPs
Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, data management, 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, including SOP development
Manage clinical budgets
Perform other duties, as necessary
Some travel required

Skills Needed:

Ability to work in a smaller team environment with a willing, all hands on deck attitude
Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
High attention to detail, accuracy, and quality and 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 as well as Google office tools including sheets and slides

Educational Requirements & Work Experience:

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 $180,000 to $225,000, cash bonus, and stock options.

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 any unsolicited resumes for these positions will be considered to be free referrals.

Required profile