Join Cleerly: Head of Clinical Development, Scientific Affairs

About Cleerly

Cleerly is a pioneering healthcare company with locations in Denver, Colorado, and New York, New York. We are transforming the diagnosis, treatment, and tracking of heart disease. Founded in 2017 by a globally recognized cardiologist, our growing team includes top-tier professionals in engineering, operations, medical affairs, marketing, and sales. In 2022, we secured $223M in Series C funding to fuel our rapid growth and mission support.

Our mission is to establish a new standard of care for heart disease through AI-driven precision diagnostic solutions aimed at preventing heart attacks. Our technology surpasses traditional heart disease metrics, providing comprehensive quantification and characterization of atherosclerosis in each heart artery. Supported by over a decade of leading clinical trials, Cleerly identifies crucial findings that could indicate elevated heart attack risks even absent symptoms.

About the Opportunity

We seek an MD with extensive clinical research experience in cardiovascular medicine and/or cardiovascular imaging. The ideal candidate is passionate about revolutionizing coronary artery disease treatment and lowering the incidence of major cardiovascular events through groundbreaking clinical trials.

About the Team

Under the guidance of the Chief Scientific Officer, the head of clinical development oversees significant research projects, such as randomized trials and multicenter registries. Acting as a sponsor representative to CROs, academic leaders, and industry partners, you will also lead internal Scientific & Regulatory Affairs initiatives, including Data Science. Our diverse team boasts expertise in imaging core laboratory operations, clinical research, statistical data management, quality and regulatory affairs, and more. We support both internal product development and research evidence generation efforts.

Key Responsibilities

Clinical Trials

• Serve as sponsor representative towards academic trial leadership, partners, and contracts.
• Oversee clinical trial conduct, progress, relationships, compliance, and budgets.
• Facilitate cross-functional team collaborations for successful trial execution.
• Design clinical trials, optimize study protocols, and write protocols based on medical expertise.
• Maintain clinical and scientific expertise through literature review, medical/scientific meetings, and consulting with experts and stakeholders.
• Present findings at scientific and medical advisory board meetings and regulatory meetings.
• Contribute to regulatory filings by authoring clinical sections for IDEs and other documentation.

Regulatory Compliance and Quality

Ensure adherence to ethical and regulatory standards set by the FDA and relevant governing bodies across all studies.

Cleerly Core Laboratory

Provide medical oversight, assist in trial design, and optimize study protocols utilizing medical expertise.

Publications and Scientific Writing

• Contribute to the strategic scientific focus and publication plan for Scientific Affairs.
• Lead scientific review processes and scientific writing for multiple publications.

Business Development

• Act as a spokesperson representing Cleerly’s expertise and vision to external stakeholders.
• Stay informed about scientific publications, guidelines, market access, and regulatory aspects.
• Drive clinical trials and research core laboratory growth by building strategic relationships with pharmaceutical, biotechnology, and medical device companies, CROs, and imaging laboratories.
• Maintain a network of trusted physician advisors for the CTSU core lab.

Requirements

• Postgraduate degree MD or PhD
• 5+ years of clinical trials experience, demonstrating profound understanding of the clinical research process.
• Impressive publication record, showcasing scientific writing and leadership in publication efforts.
• Exceptional organizational and time management skills to handle multiple projects effectively.
• Strong verbal and written communication skills, including effective presentation abilities and experience as a primary author/contributor to peer-reviewed journals and scientific meetings.

Preferred Qualifications

• Advanced Degree: MPH or PhD, illustrating a blend of medical, research, business, and public health acumen.
• Regulatory Expertise: Comprehensive understanding and interpretation of GCP/ICH/FDA standards and guidelines, plus proficiency in managing clinical research resources.

Salary: $230,000-$300,000