National Head of OCS Kidney Program

Trans Medics is the global leader in portable normothermic organ perfusion for heart, lung, and liver transplantation. In 2027, we will introduce the OCS Kidney System globally, the first organ system built on the OCS Gen-3.0 platform. We are scaling our internal and external product and clinical development efforts to begin global clinical activities with the OCS Kidney in H2 2027.

To lead the clinical execution of this strategic program, we are creating a new surgical and clinical leadership role. The Head of the OCS Kidney Program is accountable for all preclinical and clinical aspects of the program, from development of the clinical use model, through clinical development and interactions with the FDA and international regulatory bodies, to commercial launch in the U.S. and Europe.

Partnering closely with every functional area of the business, this leader will help shape strategic decisions for the OCS Kidney System and share accountability for clinical trial success, global revenue and volume targets, customer adoption, and long-term program success.

Product Development, Preclinical Development & Strategy Own all clinical input into product development, design validation, and regulatory readiness for the OCS Kidney program Optimize clinical use workflow for the OCS Kidney to maximize clinical value and adoption Develop and refine the OCS Kidney use model from R&D through clinical application, ensuring alignment with product design, workflow requirements, and clinical practice. This role will own:
Design and execution of all preclinical studies required by U.S. and international regulatory bodies to enable initiation of the first-in-human clinical trial Development of the clinical trial protocols and statistical analysis plans in partnership with Clinical Affairs and Regulatory leadership Development, and execution of surgical and clinical training requirements and protocols for internal and external users of the OCS Kidney System Clinical requirements for OCS Kidney digital control, remote monitoring, and user experience within the OCS NOP Connect digital ecosystem, in partnership with the Digital Development team Clinical requirements for all future OCS Kidney product improvements and redesigns, based on clinical customer feedback and usability findings Clinical Trial Support and Clinical User Interaction Partner in selecting the initial clinical trial centers globally Lead clinical outreach to promote the program, in collaboration with the Commercial and Clinical Affairs teams Own engagement and relationships with surgical leaders at ALL U.S. trial centers Serve as the program’s clinical representative before the CEC and DSMB for all OCS Kidney trials Accountable for meeting enrollment targets and ensuring timely collection and cleaning of trial data to support on-time regulatory submissions with Clinical Affairs Own all clinical communications to trial sites regarding trial progress Accountable for all clinical data presentations to U.S. and international regulatory bodies for the OCS Kidney program and clinical users Lead clinical data interpretation and positioning for the final clinical study reports of the OCS Kidney trials Clinical Adoption and Commercial Support Build and maintain strong relationships with OCS Kidney System users globally, including individual clinicians, hospital systems, and OPOs Lead the planning and execution of user and investigator meetings for the OCS Kidney program Partner with the Commercial team to introduce the OCS Kidney System to clinical programs globally Monitor and report OCS Kidney System utilization, device-related issues, user feedback, and other clinically relevant information…