Sr Clinical Manager, CEG

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 through innovation, advanced analytics, and evolving regulatory science. 
•    Act as the Clinical representative for participation in internal and external regulatory audits.
•    Coordinate multiple projects at one time and provide regular reports to Management and other stakeholders as required.
•    Develop, maintain, and continuously improve global clinical evidence procedures, templates, and processes, ensuring alignment with evolving regulatory requirements, industry standards, and best practices.
•    Monitor emerging regulatory guidance and clinical evidence best practices to ensure evidence generation approaches remain aligned with evolving global expectations

•    Proactively manages performance and team dynamics to ensure that a fair, professional and high-performance environment, aligned with company values is maintained. Develops individual and organizational capabilities to build bench strength while delivering results now and into the future. 
•    Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity.  All CMA colleagues are expected to perform with the highest levels of professionalism, service and ethics in order to strengthen the Teleflex brand and relationship with our customers. 
•    Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize both process and performance gaps.  Develops solutions and leads the team to deliver improving results. Serves as a leader to exemplify continuous improvement thought processes and focus.  
•    Culture and Values – Exemplifies Teleflex values and ensures a fair, open and productive climate that is engaging, ethical and legally compliant.  Leads team to work effectively across boundaries in a complex matrix environment
•    Perform additional duties as assigned

Education / Experience Requirements

•    Bachelor's degree in Life Sciences, Biomedical Engineering, Clinical Research, Epidemiology, Public Health, or a related scientific discipline. Master's degree or PhD preferred.
•    Minimum 5-7 years' experience within Clinical Affairs, Clinical Evidence Generation, Regulatory Affairs, Medical Affairs, or related functions in the medical device industry.
•    Experience critically appraising scientific literature and interpreting clinical evidence to support regulatory decision-making.
•    Demonstrated experience leading Clinical Evaluation activities, including CERs, CEPs, PMCF, SSCPs, and clinical evidence generation throughout the product lifecycle.
•    Demonstrated experience designing and supporting clinical investigations, PMCF studies, observational studies, or Real World Evidence (RWE) studies.
•    Working knowledge of Real World Data (RWD) sources, including electronic health records, registries, and healthcare databases, and their application in evidence generation.
•    Experience interacting with Notified Bodies, Competent Authorities, FDA, or other global regulatory authorities.
•    Demonstrated people leadership experience, with the ability to coach, develop, and build high-performing teams.
•    Experience collaborating effectively within cross-functional and global matrix organizations.

Specialized Skills / Other Requirements

•    Strong understanding of EU MDR clinical evidence requirements, PMCF, CERs, and Good Clinical Practice (GCP).
•    Strong understanding of clinical study design, evidence synthesis, clinical data interpretation, and fundamental biostatistical principles.
•    Knowledge of emerging Real World Evidence frameworks, including FDA RWE guidance and NEST, is desirable.
•    Familiarity with advanced analytics, AI-enabled evidence generation, digital health technologies, and modern clinical data approaches is an advantage.
•    Excellent scientific writing, communication, stakeholder management, and influencing skills.
•    Strong analytical thinking, problem-solving, and organizational skills, with the ability to manage multiple priorities.
•    Fluent in English (written and spoken). 

TRAVEL REQUIRED: 10-20%.

WORKING ENVIRONMENT:
☒ Office/Professional    (Hybrid)

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