Head of Clinical Development, Scientific Affairs

About Cleerly

We’re Cleerly – a healthcare company based in Denver, Colorado and New York, New York that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which will enable rapid growth and continued support of our mission.

Cleerly is creating a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks.

About the Opportunity

The ideal candidate is an MD that has significant prior experience in clinical research, including clinical trials and scientific writing as well as clinical experience in the area of cardiovascular medicine and/or cardiovascular imaging and is eager to join a team that is conducting breakthrough clinical trials that will reshape the way we treat coronary artery disease and lower rates of major cardiovascular events.

About the Team

Under the direction of the Chief Scientific Officer, the head of clinical development leads significant research projects such as randomized trials, or multicenter registries as a sponsor representative to CRO’s, academic leaders and industry partners as well as an internal lead for Scientific & Regulatory Affairs, including Data Science. These teams are a diverse group of individuals with experience in imaging core laboratory operations, clinical research operations, clinical data management, statistics and data science, and quality and regulatory affairs. We also support both internal product development and quality operations as well as research and evidence generation.

The position provides a unique opportunity for those who enjoy extending their physician scientist skill set into a comprehensive purpose driven effort that spans all facets of an early stage digital health care strategy company (regulatory, technology, commercial, market access, etc.).

Responsibilities

1. Clinical Trials
1. Sponsor representative towards academic trial leadership, partners and contracts;
2. Oversight of the conduct, progress, relationships, compliance and budgets of clinical trials
3. Overseeing collaborations with cross-functional teams to ensure successful trial execution (Product, Regulatory).
4. Assist in the design of clinical trials, leveraging medical expertise to optimize study protocols and objectives; actively write protocols
5. Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
6. Present at scientific and medical advisory board meetings and at regulatory meetings
7. Contribute to company’s planned regulatory filings including authoring clinical sections for IDEs and other documents for regulatory filings.
8. Regulatory Compliance and Quality: Ensure that all studies conducted adhere to ethical and regulatory standards set forth by the FDA and other relevant governing organizations
9. Cleerly Core Laboratory - Medical Oversight, assist in the design of clinical trials, leveraging medical expertise to optimize study protocols and objectives; actively write protocols
10. Publications and Scientific Writing
11. Contribute to strategic scientific focus and publication plan for Scientific Affairs.
12. Lead scientific review process and scientific writing for multiple publications.
2. Business Development
1. Act as a spokesperson for company representing expertise and vision to external stakeholders
2. Stay up-to-date with scientific publications, guidelines, market access and regulatory aspects
3. Drive growth in the clinical trials and research core laboratory business by establishing and nurturing strategic relationships with pharmaceutical, biotechnology, and medical device companies, contract research organizations, and other core imaging laboratories.
4. Develop and maintain relationships with physicians who will review medical images and serve as advisors for the CTSU core lab, fostering a network of trusted experts.

Job duties, activities, and responsibilities are subject to change by our company.

Requirements:

1. Postgraduate degree MD or PhD
2. A minimum of 5+ years of clinical trials experience, demonstrating a deep understanding of the clinical research process.
3. Publication record demonstrating excellent skills in scientific writing and leading publication efforts.
4. Organizational Skills: Exceptional organizational and time management skills to manage multiple projects simultaneously and effectively.
5. Communication Skills: Strong verbal and written communication skills, including effective presentation abilities. Experience serving as primary author and contributor to peer-reviewed journal articles and presentations at scientific meetings.

Preferred:

1. Advanced Degree: MPH or PhD preferred, showcasing a combination of medical and research, business and public health acumen.
2. Regulatory Expertise: Strong understanding of and the ability to interpret GCP/ICH/FDA standards and guidelines, as well as a clear comprehension of internal and external resource management in clinical research.

Salary: $230,000-$300,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.

OUR CORE VALUES:

• We strive to earn trust.
• We value and seek out differences.
• We obsess over client success.
• Our curiosity sparks change.

Why you should apply:

• PURPOSE: Cleerly’s purpose is to create a world without heart attacks. With our new paradigm for precision heart care, we will leave big footprints in the sands of time. Help us make that a reality!
• GROWTH: We prioritize learning and growth. As a rapid growth company, there is always space for new challenges and responsibilities.
• OWNERSHIP: Everyone on the team contributes to our success, so everyone has equity in the company through our employee stock option incentive plan.
• BENEFITS: Cleerly offers a variety of medical, dental, and vision plans, designed to fit you and your family’s needs. Along with stock options and a 401(k) match program that helps you invest in the future, Cleerly also offers company wide holidays, a winter break, as well as a self-managed PTO policy. Additional benefits include, wellness, home office and learning & development stipends and parental leave benefits for new parents.

Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences.

OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

Job duties, activities and responsibilities are subject to change by our company.