Clinical Strategy Lead

Company Overview

Argon Medical Devices is a global manufacturer of specialty medical products. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture.

Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

This position is not eligible for visa sponsorship.

The Clinical Strategy Lead is responsible for developing and executing clinical evidence strategies across the product lifecycle. This role partners Clinical Affairs, Regulatory Affairs, R&D, Marketing, and Medical Affairs to identify evidence gaps, evaluate clinical opportunities, and design studies that support product development, regulatory submissions, market access, and commercial objectives. The Clinical Strategy Lead serves as the clinical architect for prospective studies, retrospective studies, investigator‑initiated studies, post‑market studies, and new product development initiatives.

• Develop and maintain clinical development strategies that support product development, regulatory submissions, label expansion opportunities, post‑market evidence generation, and commercial objectives.
• Identify clinical evidence gaps and recommend appropriate evidence generation strategies to support business and regulatory needs.
• Lead development of Clinical Development Plans and clinical evidence roadmaps across the product lifecycle.
• Evaluate and recommend prospective studies, retrospective studies, registries, investigator‑initiated studies, post‑market studies, and other evidence generation activities.
• Monitor industry trends, competitive clinical evidence, and evolving regulatory expectations to support future clinical strategy.

• Design prospective, retrospective, observational, registry, and investigator‑initiated studies.
• Develop study concepts, synopses, full clinical protocols and supporting scientific rationale.
• Define study endpoints, inclusion and exclusion criteria, statistical assumptions, and study success measures.
• Support study feasibility assessments, enrollment projections, timelines, budgets, and resource planning.
• Collaborate with study teams, investigators, and external partners to support successful study execution.
• Provide scientific and strategic guidance throughout the study lifecycle, including study startup, conduct, analysis, and dissemination of results.
• Serve as a clinical resource and may support management of clinical studies and strategic initiatives as business needs require.

• Serve as a key clinical partner to Medical Affairs, Regulatory Affairs, Research and Development, Quality, Marketing, and Commercial teams.
• Build and maintain relationships with investigators, key opinion leaders, scientific advisors, and external clinical experts.
• Provide clinical input into new product development activities, design reviews, clinical development plans, risk assessments, and product claims.
• Present clinical strategies, study concepts, and evidence plans to leadership and cross‑functional stakeholders.
• Communicate effectively with internal and external stakeholders, including investigators, key opinion leaders, contract research organizations, and industry partners.

• Bachelor’s degree in a scientific, clinical, engineering, or healthcare‑related discipline.
• Minimum of 7 years of experience in Clinical Affairs, Clinical Research, Medical Affairs, Regulatory Affairs, or related medical device functions.
• Experience developing clinical study protocols, study concepts, or clinical development plans.
• Experience supporting clinical studies in the medical device industry.
• Strong knowledge of clinical research methodologies, clinical…