Heartflow
HeartFlow is a medical technology company advancing the diagnosis and management of coronary artery disease. Our flagship product is an AI-driven, non-invasive cardiac test called the HeartFlow FFRCT Analysis, which provides a color-coded, 3D model of a patient’s coronary arteries to indicate the impact of blockages on blood flow. HeartFlow offers an integrated heart care solution across the CCTA pathway to identify stenoses, assess coronary blood flow, and quantify coronary atherosclerosis. We are growing our pipeline and team to revolutionize precision heartcare.
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 timelines and maintain high quality standards. The ideal candidate will have demonstrated clinical research study execution experience, exceptional organizational skills, attention to detail, and comfort working in a fast-paced startup environment. Responsibilities
Leads a team of clinical trial professionals Participates in clinical research activities including management of clinical study sites, study documentation, and project management tasks Develops clinical trial and program timelines, enrollment projections, documents, and instructional materials to support trial execution (including project management, communication, monitoring, recruitment, risk mitigation, and contingency plans) Conducts study start-up activities including development of protocols, informed consent forms, source document worksheets, and training materials Reviews site regulatory documents (informed consents, IRB approvals, research agreements/budgets) for compliance with study requirements and GCPs Maintains effective relationships with investigators, coordinators, and vendors including core labs and CROs Manages vendor and CRO activities and tracks deliverables to ensure timelines and budgets are met Participates in and leads process improvement initiatives within the department and cross-functionally Manages clinical trial budgets and accounting Performs other duties as necessary Travel may be required Qualifications
Ability to work in a smaller team environment with a hands-on, all-hands-on-deck attitude Ability to manage multiple tasks with shifting priorities Exceptional 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 verbal English communication skills Proficiency with 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 experience managing a CRO Experience in cardiovascular medical device clinical research is a plus Compensation & Equal Opportunity
A reasonable estimate of the base salary compensation range is $210,000 to $260,000, plus 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 on the basis of race, color, religion, marital status, age, national origin, ancestry, disability, medical condition, pregnancy, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected by law.
#J-18808-Ljbffr
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 timelines and maintain high quality standards. The ideal candidate will have demonstrated clinical research study execution experience, exceptional organizational skills, attention to detail, and comfort working in a fast-paced startup environment. Responsibilities
Leads a team of clinical trial professionals Participates in clinical research activities including management of clinical study sites, study documentation, and project management tasks Develops clinical trial and program timelines, enrollment projections, documents, and instructional materials to support trial execution (including project management, communication, monitoring, recruitment, risk mitigation, and contingency plans) Conducts study start-up activities including development of protocols, informed consent forms, source document worksheets, and training materials Reviews site regulatory documents (informed consents, IRB approvals, research agreements/budgets) for compliance with study requirements and GCPs Maintains effective relationships with investigators, coordinators, and vendors including core labs and CROs Manages vendor and CRO activities and tracks deliverables to ensure timelines and budgets are met Participates in and leads process improvement initiatives within the department and cross-functionally Manages clinical trial budgets and accounting Performs other duties as necessary Travel may be required Qualifications
Ability to work in a smaller team environment with a hands-on, all-hands-on-deck attitude Ability to manage multiple tasks with shifting priorities Exceptional 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 verbal English communication skills Proficiency with 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 experience managing a CRO Experience in cardiovascular medical device clinical research is a plus Compensation & Equal Opportunity
A reasonable estimate of the base salary compensation range is $210,000 to $260,000, plus 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 on the basis of race, color, religion, marital status, age, national origin, ancestry, disability, medical condition, pregnancy, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected by law.
#J-18808-Ljbffr