National Head of OCS Kidney Program

TransMedics•Andover, MA

About The Position

TransMedics is creating a surgical and clinical leadership role to lead the clinical execution of the OCS Kidney System program, which is planned for global introduction in 2027. The role is accountable for the program’s preclinical and clinical activities, from development of the clinical use model and clinical development through interactions with the FDA and international regulatory bodies and commercial launch in the U.S. and Europe. Working closely with all business functions, the leader will help shape strategic decisions and share accountability for clinical trial success, global revenue and volume targets, customer adoption, and long-term program success. The role owns clinical input to product development, design validation, and regulatory readiness; development of the clinical use workflow and use model; required preclinical studies; clinical trial protocols and statistical analysis plans; and surgical and clinical training. It also establishes clinical requirements for digital controls, remote monitoring, user experience, and future product improvements. The Head leads clinical relationships with trial centers and users, supports enrollment and trial data quality, represents the program before clinical oversight bodies and regulators, and guides clinical data interpretation and reporting. The role also supports commercial introduction and adoption, manages clinical user feedback and field complaints with Quality, and develops customer-facing clinical content and scientific communications. The position includes performing liver and kidney donor procurement missions in the Northeast or elsewhere as needed. This is an executive role with 24/7 accountability. The leader participates in the executive on-call escalation rotation and must be reachable during active critical cases. Regular presence in the Clinical Command Center is required, along with travel to transplant centers, OPOs, and industry meetings and occasional observation of procedures in clinical settings. TransMedics plans to relocate its headquarters to Somerville, Massachusetts by 2028; specific timing and role impact may vary.

Requirements

MD with advanced surgical training in abdominal organ transplantation.
At least 7 years of independent surgical experience, including abdominal organ procurement.
Uphold the highest moral and ethical standards.
Demonstrated leadership ability to build, manage, and develop teams while fostering engagement and accountability.
Exceptional customer-facing skills and ability to engage effectively with clinical staff and advocate for the OCS platform.
Ability to lead calmly and decisively with clear direction in time-sensitive, mission-critical environments.
Exceptional interpersonal and communication skills, with the ability to communicate effectively with internal teams and clinical sites at all levels.
Detail-oriented, highly organized, hands-on self-starter.
Proven ability to collaborate effectively across functions and at all levels of the company.
Track record of successfully managing complex clinical and/or commercial programs and projects.
Demonstrated ability to perform in a fast-paced, dynamic environment under the time and stress constraints inherent to donor surgery and organ transplantation.
Maintain surgical availability to meet mission demand and be reachable during active critical cases as part of 24/7 accountability.

Responsibilities

Own all clinical input into product development, design validation, and regulatory readiness for the OCS Kidney program.
Optimize the clinical use workflow and develop and refine the OCS Kidney use model from R&D through clinical application.
Design and execute preclinical studies required by U.S. and international regulatory bodies to enable the first-in-human clinical trial.
Develop clinical trial protocols and statistical analysis plans in partnership with Clinical Affairs and Regulatory leadership.
Develop and execute surgical and clinical training requirements and protocols for internal and external users.
Define clinical requirements for digital control, remote monitoring, user experience, and future product improvements in collaboration with relevant teams.
Partner in selecting initial global clinical trial centers and lead clinical outreach to promote the program.
Own engagement and relationships with surgical leaders at all U.S. trial centers.
Represent the program clinically before the CEC and DSMB for OCS Kidney trials.
Meet enrollment targets and ensure timely collection and cleaning of trial data to support regulatory submissions.
Own clinical communications to trial sites regarding trial progress.
Present clinical data to U.S. and international regulatory bodies and clinical users, and lead interpretation and positioning of data for final clinical study reports.
Build and maintain relationships with OCS Kidney System users globally, including clinicians, hospital systems, and OPOs.
Plan and execute user and investigator meetings, and partner with Commercial to introduce the system to clinical programs globally.
Monitor and report system utilization, device-related issues, user feedback, and other clinically relevant information to stakeholders.
Lead clinical assessment of field and user complaints through resolution in partnership with Quality.
Develop and own clinical content for customer communications, including PIBs, Clinical Use Models, and field notifications.
Support scientific presentations and draft clinical abstracts and publications for OCS Kidney users.
Participate in strategic leadership meetings focused on the OCS Kidney program.
Perform liver and kidney donor procurement missions in the Northeast region or elsewhere as needed.
Perform other duties as assigned.

Benefits

Medical coverage with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental insurance
Vision insurance
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short-term disability
Long-term disability
401(k) plan
Pet insurance
Employee Stock Purchase Plan
Paid time off
Wellness resources
Potential bonus and equity eligibility