Director, Clinical Operations

HeartFlow, Inc; United States; Remote; USD 180,000 - 225,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Operations to lead clinical research efforts. This pivotal role involves managing clinical trials, ensuring compliance with regulatory standards, and collaborating with various stakeholders to enhance the quality of clinical studies. The ideal candidate will bring over a decade of experience in clinical research, demonstrating exceptional leadership and organizational skills. Join a forward-thinking company that is revolutionizing heart care and making a significant impact on patient outcomes. If you're passionate about advancing medical technology and thrive in a dynamic environment, this opportunity is perfect for you.

Benefits

Cash Bonus

Stock Options

Qualifications

• 10+ years of experience in clinical research and team management.
• Strong knowledge of ICH Guidelines and FDA regulations.

Responsibilities

• Oversee and manage all clinical operational activities.
• Lead a team of clinical trial professionals and manage study sites.
• Develop trial timelines and ensure compliance with regulations.

Skills

Clinical Research Management

Project Management

Regulatory Compliance

Team Leadership

Attention to Detail

Communication Skills

Microsoft Office Suite

Google Office Tools

Education

Bachelor's Degree in Science or Health Related Field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Google Sheets

Google Slides

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 CT 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 (RoadMapAnalysis), assess coronary blood flow (FFR CT 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 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.

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

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.