You will collaborate closely with Regulatory, Biostatistics, Medical Safety, and R&D teams, ensuring that our clinical strategies align with scientific rigor, regulatory requirements, and market needs. This role does not involve direct clinical trial management or operational oversight—instead, it focuses on the scientific and strategic aspects of clinical research. Develop clinical trial strategies, shaping study designs based on regulatory requirements and competitive insights. Author and review clinical trial protocols, regulatory documents, and study-related publications. Interpret and analyze clinical data, working closely with biostatistics to ensure robust scientific conclusions. Act as a clinical subject matter expert (SME), providing insights for new product development and post-market evaluations. Support regulatory submissions, presenting scientific evidence to regulatory bodies and internal stakeholders. Engage with Key Opinion Leaders (KOLs) and study investigators, fostering strong scientific collaborations. Stay informed on evolving clinical trends, competitor data, and regulatory updates to refine our clinical strategies. We are looking for a highly skilled Clinical Scientist with a passion for evidence-based decision-making and cross-functional collaboration. You are analytical, detail-oriented, and able to translate complex scientific data into actionable insights. Advanced degree (master's or PhD) in medical, biological sciences, or a related field. Minimum 7 years of experience in clinical research within the medical device industry. In-depth knowledge of Good Clinical Practices (GCP), ISO 14155, and FDA regulations. Experience in clinical trial design, data interpretation, and scientific writing. Proven ability to collaborate cross-functionally within a clinical research setting, such as regulatory, biostatistics and the medical affairs team. PhD in a relevant field. Background in structural heart or interventional cardiology (strong plus).
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