Design and deliver clinical performance study strategy, protocols, and reports for IVDR and CDx programs. Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design. Partner closely with
Responsible for leading and advancing the Clinical Quality Risk Management (QRM) framework, to strengthen clinical quality governance and support clinical program-level risk oversight. The role ensures that risk-based quality management principles are
Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates; Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head; Perform and coordinate PV
Define and execute EU regulatory strategies in alignment with global development plans. Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities. Lead preparation and execution of Scientific Advice,
In this pivotal role, you will design and execute the innovative data strategy that underpins our clinical development pipeline, ensuring the highest standards of scientific rigor and regulatory compliance across all trials and study phases fundamental to
Lead the multidisciplinary Clinical Team at development-program level, providing scientific direction, strategic alignment and accountability across the program. Shape innovative clinical development strategies that maximize the compound's value