National Head of OCS Kidney Program

Job Description:TransMedics 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.ESSENTIAL JOB RESPONSIBILITIES & DUTIES:Product Development, Preclinical Development & StrategyOwn all clinical input into product development, design validation, and regulatory readiness for the OCS Kidney programOptimize clinical use workflow for the OCS Kidney to maximize clinical value and adoptionDevelop and refine the OCS Kidney use model from R&D through clinical application, ensuring alignment with product design, workflow requirements, and clinical practiceThis 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 trialDevelopment of the clinical trial protocols and statistical analysis plans in partnership with Clinical Affairs and Regulatory leadershipDevelopment, and execution of surgical and clinical training requirements and protocols for internal and external users of the OCS Kidney SystemClinical requirements for OCS Kidney digital control, remote monitoring, and user experience within the OCS NOP Connect digital ecosystem, in partnership with the Digital Development teamClinical requirements for all future OCS Kidney product improvements and redesigns, based on clinical customer feedback and usability findingsClinical Trial Support and Clinical User InteractionPartner in selecting the initial clinical trial centers globallyLead clinical outreach to promote the program, in collaboration with the Commercial and Clinical Affairs teamsOwn engagement and relationships with surgical leaders at ALL U.S. trial centersServe as the program’s clinical representative before the CEC and DSMB for all OCS Kidney trialsAccountable for meeting enrollment targets and ensuring timely collection and cleaning of trial data to support on-time regulatory submissions with Clinical AffairsOwn all clinical communications to trial sites regarding trial progressAccountable for all clinical data presentations to U.S. and international regulatory bodies for the OCS Kidney program and clinical usersLead clinical data interpretation and positioning for the final clinical study reports of the OCS Kidney trialsClinical Adoption and Commercial SupportBuild and maintain strong relationships with OCS Kidney System users globally, including individual clinicians, hospital systems, and OPOsLead the planning and execution of user and investigator meetings for the OCS Kidney programPartner with the Commercial team to introduce the OCS Kidney System to clinical programs globallyMonitor and report OCS Kidney System utilization, device-related issues, user feedback, and other clinically relevant information to key stakeholders on a defined cadenceLead the clinical assessment of all field and user complaints through resolution, in direct partnership with the Quality teamDevelop and own the clinical content of all OCS Kidney System customer communications, including PIBs, Clinical Use Models, and field notificationsSupport the development of scientific presentations and draft clinical abstracts and publications for OCS Kidney usersOther Surgical and Strategic TasksParticipate in all strategic leadership meetings focused on the OCS Kidney programPerform liver and kidney donor procurement missions in the Northeast region, or elsewhere as neededPerform other TransMedics duties as assignedJOB REQUIREMENTS:MD with advanced surgical training in abdominal organ transplantation7+ years of independent surgical experience including abdominal organ procurementUpholds the highest moral and ethical standardsProven leader with the ability to build, manage, and develop teams while fostering a strong culture of engagement and accountabilityExceptional customer-facing skills, with a demonstrated ability to engage effectively with clinical staff at sites and serve as a strong advocate for the OCS platformAbility to lead teams calmly and decisively, with clear direction, in time-sensitive, mission-critical environmentsExceptional interpersonal and communication skills, and ability to communicate effectively with internal teams and clinical sites at all levels of the organizationDetail-oriented, highly organized, hands-on self-starterProven ability to collaborate effectively across functions and at all levels of the companyProven track record of successfully managing complex clinical and/or commercial programs and projectsDemonstrated ability to perform in a fast-paced, dynamic environment under the time and stress constraints inherent to donor surgery and organ transplantationHow success is measuredTimely delivery of results and executes corporate goals is paramountBuilds a high-performing team and strong bench of talent accountable for day-to-day execution of the program’s critical tasks360-degree feedback from peers, direct reports, managers, and external clinical users and collaboratorsMaintains a calm, composed demeanor under pressureProvides the highest quality surgical service and maintains surgical availability to meet mission demandMaintains zero tolerance for ethical, moral, or interpersonal misconduct with peersWorking conditionsExecutive role with 24/7 accountability. Participates in the executive on-call escalation rotation and must be reachable during active critical cases. Requires regular presence in the Clinical Command Center; travel to transplant centers, OPOs, and industry meetings; and occasional observation of procedures in clinical settings.As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary.Every Organ Wasted is a Life Not Saved.TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $408,150-$509,050, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.Employee Benefit:Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insurance Employee Stock Purchase PlanTransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.SummaryLocation: Andover, MAType: Full time