Sr Clinical Manager, CEG

Expected Travel : Up to 25% Requisition ID : 14214   About Teleflex Incorporated   As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.    Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.   At Teleflex, we are empowering the future of healthcare.  For more information, please visit teleflex.com. Position Summary

The Senior Clinical Manager – Clinical Evidence Generation is responsible for leading the Clinical Evidence Generation team, ensuring the delivery of high-quality clinical evidence that supports regulatory compliance, product lifecycle management, and business objectives across the Anaesthesia, Urology, and Interventional Urology portfolios. The role provides scientific leadership for MDR clinical evidence activities, including Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Clinical Follow-up (PMCF), Summary of Safety and Clinical Performance (SSCPs). Working collaboratively with Medical Affairs, Clinical Operations, Regulatory Affairs, Design Assurance, Biostatistics, and Health Economics & Market Access, the role supports clinical evidence generation and ensures evidence is scientifically robust, compliant, and aligned with evolving regulatory expectations. The role also strengthens the organization's Real-World Data (RWD) and Real World Evidence (RWE) capabilities by advancing innovative evidence generation approaches, supporting cross-functional evidence strategies, and developing the Clinical Evidence team's capability Principal Responsibilities

•    Lead the Clinical Evidence Generation team, ensuring delivery of high-quality clinical evidence supporting MDR compliance and global regulatory requirements.  •    Lead and develop a team of Clinical Scientists/Medical Writers responsible for CERs, CEPs, PMCF, SSCPs, literature surveillance, and other lifecycle clinical evidence activities.  •    Provide scientific oversight of PMCF studies, clinical investigations, and Real World Evidence (RWE) activities from study design through data interpretation, ensuring the generation of robust clinical evidence to support regulatory, clinical, and business needs.Strengthen the organization's Real World Data (RWD) and Real World Evidence (RWE) capabilities by advancing evidence generation methodologies, innovative study designs, and regulatory best practices.  •    Support the Medical Affairs Strategy team in the development and execution of Integrated Evidence Plans (IEPs) by providing expertise in clinical evidence generation and regulatory evidence requirements.  •    Provide scientific leadership in clinical study design, endpoint selection, clinical data interpretation, evidence synthesis, and benefit-risk assessment in collaboration with Biostatistics.  •    Partner with Health Economics & Market Access to incorporate payer-relevant evidence considerations into clinical study planning where appropriate.  •    Act as the clinical evidence subject matter expert for interactions with Notified Bodies, Competent Authorities, the FDA, and other regulatory agencies.  •    Collaborate with Regulatory Affairs, R&D, Quality, Medical Affairs, and external experts to ensure evidence generation activities align with regulatory expectations and business priorities.  •    Drive continuous improvement in clinical evidence generation