Medical Director
 FIRE1

Position Overview

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FIRE1 is a Dublin-based medical device startup developing a breakthrough solution to physician-guided, patient-led volume management for heart failure patients. Described as the “Dexcom of Heart Failure”, FIRE1 is poised to disrupt heart failure management much like Dexcom did in the diabetes space. FIRE1 has raised $200M to-date from the biggest names in MedTech: Medtronic, Lightstone Ventures, Gilde Healthcare, NEA, Novo Nordisk, and others. Clinical data published in JCF shows 100% safety with data suggesting that the disease-modifying potential of the technology will present a complete paradigm shift in the treatment of heart failure. 

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• Press Release: FIRE1 Secures $120 Million Financing to Revolutionize Heart Failure Care

• Publication: JACC Paper

 

We have partnered with John Britton, COO, and Brien Neudeck, VP of Clinical, to identify a full-time Medical Director to work closely with the VP of Clinical to execute on ongoing and future clinical trials by functioning as a peer to participating physicians and supporting timely enrollment efforts. This position will also support the regulatory team through upcoming IDE and PMA submissions.​​

 

Responsibilities​​

 

1. Clinical Trial Strategy and Execution:

• Develop and oversee clinical strategies for cardiac therapies, devices, or treatments.

• Protocol Development & Refinement: Support and coordinate the medical input into the refinement of the trial protocols, ensuring alignment with scientific evidence, regulatory requirements, and commercial objectives. This includes detailed review of inclusion/exclusion criteria, endpoints, and statistical analysis plans.

• Site Selection & Investigator Management: Provide day-to-day medical expertise in the selection and qualification of investigational sites, ensuring they possess the necessary expertise and resources. Cultivate strong relationships with principal investigators, serving as a key medical resource and ensuring adherence to the protocol.

• Data Monitoring & Safety Oversight: Support robust data monitoring processes to ensure patient safety and data integrity. Proactively identify and address potential safety signals, including adverse events and serious adverse events, in collaboration with the wider Clinical team.

• Clinical Operations Collaboration: Work as senior member of the team to ensure efficient trial execution, including patient recruitment, data collection, and site management.

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2. Regulatory Affairs & Compliance:

• Regulatory Submissions: Support medical review and preparation of clinical trial applications, investigational device exemptions (IDEs), and other regulatory submissions.

• Agency Interactions: Serve as a medical liaison with regulatory agencies (e.g., FDA, EMA), addressing queries and providing medical expertise during inspections and meetings.

• Compliance & Audit Readiness: Work with the team to ensure the trial is conducted in full compliance with GCP, and all applicable regulatory requirements. Prepare for and participate in regulatory audits and inspections.

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3. Medical & Scientific Leadership:

• Medical Expertise & Guidance: Coordinate medical and scientific guidance to the clinical development team, including clinical research associates, data managers, and biostatisticians.

• Data Analysis & Interpretation: Manage the medical review and interpretation of clinical trial data, ensuring accuracy, consistency, and clinical relevance. Contribute to the preparation of clinical study reports, publications, and presentations.

• Literature Review & Competitive Analysis: Stay abreast of the latest scientific literature, clinical guidelines, and competitive landscape, providing insights to inform clinical development strategy.

• Key Opinion Leader (KOL) Engagement: Develop and maintain relationships with KOLs in the relevant therapeutic area.

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4. Stakeholder Engagement & Communication:

• Cross-Functional Collaboration: Foster strong collaboration with internal stakeholders, including R&D, regulatory affairs, marketing, and commercial teams.

• External Partnerships: Support relationships with contract research organizations (CROs), data safety monitoring boards (DSMBs), and other external partners.

• Represent the company at conferences, symposiums, and medical advisory boards.

• Investor & Partner Presentations: Participate in presentations to investors, potential partners, and other external stakeholders, providing medical and scientific expertise as and when required.

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5. Training & Education:

• Internal Training: Develop and deliver training programs for clinical staff and other internal stakeholders on the trial protocol, medical device technology, and relevant therapeutic areas.

• Investigator Training: Provide comprehensive training to investigators and site staff on the trial protocol, data collection procedures, and patient safety reporting.

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Qualifications & Competencies

• Medical degree (M.D. Competencies, or equivalent) with board certification in a relevant specialty, preferably heart failure

• Minimum of 3-5 years of cardiology clinical practice experience, preferably in heart failure.

• Minimum of 3-5 years of experience in clinical research, with a proven track record of successfully managing Phase III clinical trials in the medical device industry.

• Understands medical device regulatory pathways, including IDEs, 510(k)s, and PMAs.

• Knows GCP, and FDA regulations.

• Strong analytical and problem-solving skills, with the ability to interpret complex clinical data.

• Excellent communication, leadership, strategic decision-making skills, presentation, and interpersonal skills.

• Ability to thrive in a fast-paced, dynamic startup environment.

• Experience with cardiovascular devices and/or remote management of heart failure patients is a large plus

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Company Overview 

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FIRE1 is a Dublin-based MedTech company dedicated to improving outcomes for patients with heart failure through advanced remote monitoring technology. Its NORM™ system combines a minimally invasive implant with wearable and mobile tools to track fluid volume status, a key indicator in heart failure management. By enabling early intervention and continuous monitoring, the platform helps reduce hospitalizations and supports better long-term care.