Director Clinical Operations

Summary

Join Heartflow, a medical technology company revolutionizing precision heartcare with its AI-driven, non-invasive cardiac test, the Heartflow FFR CT Analysis. As the Director, Clinical Operations, you will oversee and manage all clinical operational activities, ensuring clinical studies meet or exceed timelines and maintain high quality standards. You will lead a team of clinical trial professionals, participate in clinical research activities, develop clinical trial and program timelines, and manage vendor and CRO activities. This role requires a minimum of 10 years of relevant experience, including managing a team and a CRO, and a strong understanding of clinical trial requirements and regulations.

Requirements

• 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
• 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

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

Preferred Qualifications

Experience in cardiovascular medical device clinical research a plus

Benefits

A reasonable estimate of the base salary compensation range is $180,000 to $225,000, cash bonus, and stock options