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Job Description
Clinical Strategy Lead Argon Medical Devices Inc - 3.2 Plano, TX Job Details Full-time 11 hours ago Qualifications Risk assessment Stakeholder relationship building Stakeholder management
Full Job Description 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.
ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS / AGENCIES!
!! This position is not eligible for visa sponsorship
Position Overview:
: 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.
What you will do:
: Clinical Development and Evidence Strategy 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. Study Design and Clinical Execution Support 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. Cross Functional Leadership 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. Skills for
Success:
: 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 study design, and evidence generation strategies. Ability to develop clinical development plans and translate business objectives into clinical evidence strategies. Understanding of regulatory requirements and clinical evidence expectations for medical devices, including FDA and international regulations. Strong scientific writing skills, including protocol development, study synopses, and clinical documentation. Ability to interpret and communicate clinical and scientific data to technical and non-technical audiences. Strong project management and organizational skills with the ability to manage multiple priorities. Experience building collaborative relationships across Clinical Affairs, Medical Affairs, Regulatory Affairs, Research and Development, Quality, and Commercial teams. Strong communication, presentation, and stakeholder management skills. Strategic thinking with the ability to identify opportunities, assess risks, and develop practical recommendations.
