Director, Clinical Operations at HeartFlow

San Francisco, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Technology, Healthcare, BiotechnologyIndustries

Requirements

Candidates must possess a minimum of a bachelor's degree in a science or health-related field and at least 10 years of relevant experience, including team and CRO management. Proficiency in Microsoft Office and Google tools, knowledge of ICH Guidelines, US FDA, and European clinical trial regulations, and excellent written and oral English communication skills are essential. The ability to manage multiple tasks in a fast-paced environment with shifting priorities and a high degree of attention to detail is also required.

Responsibilities

The Director, Clinical Operations will lead a team of clinical trial professionals, overseeing all clinical operational activities and ensuring clinical studies meet or exceed timelines and quality standards. Responsibilities include managing clinical study sites, documentation, and project management tasks; developing trial timelines, enrollment projections, and instructional materials; conducting study start-up activities; reviewing site regulatory documents for compliance; maintaining relationships with investigators and vendors; managing vendor and CRO activities; overseeing clinical trial budgets; and participating in process improvement initiatives. Some travel is required.

Skills

Clinical Operations

Clinical Research

Team Leadership

Project Management

Site Management

Vendor Management

Quality Assurance

Attention to Detail

Organizational Skills

HeartFlow

Non-invasive cardiac testing for heart disease

About HeartFlow

HeartFlow provides a non-invasive cardiac test that helps visualize a patient's coronary arteries in detail. This technology allows physicians to diagnose and treat heart disease more effectively without the need for invasive procedures, which reduces risks for patients and costs for healthcare providers. HeartFlow's main clients are healthcare professionals seeking safer diagnostic methods. The company offers several analyses, including FFRCT Analysis and Plaque Analysis, all of which have received FDA clearance and are available in multiple countries, including the United States, the United Kingdom, Japan, and Canada. Unlike many competitors, HeartFlow focuses on providing a comprehensive suite of analyses that enhance treatment planning. The goal of HeartFlow is to improve cardiovascular care by making it safer and more efficient for both patients and healthcare providers.

Redwood City, CaliforniaHeadquarters

2010Year Founded

$858.5MTotal Funding

SERIES_FCompany Stage

HealthcareIndustries

501-1,000Employees

Benefits

Remote Work Options

Stock Options

401(k) Company Match

Risks

Emerging AI-driven competitors could threaten HeartFlow's market share.

Algorithmic bias in AI models could lead to inaccurate diagnoses.

Integration into healthcare systems may face resistance due to complexity and cost.

Differentiation

HeartFlow offers the only combined anatomy, physiology, and plaque analysis for heart disease.

HeartFlow's non-invasive FFRCT Analysis is FDA-cleared and widely available globally.

HeartFlow's AI-driven technology provides personalized 3D heart models for precise diagnostics.

Upsides

HeartFlow closed a $215 million Series F funding round in April 2023.

The global non-invasive cardiac imaging market is projected to grow significantly.

HeartFlow's technology aligns with the trend towards value-based care in healthcare.

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