Job Description: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 & 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 to key stakeholders on a defined cadence
- Lead the clinical assessment of all field and user complaints through resolution, in direct partnership with the Quality team
- Develop and own the clinical content of all OCS Kidney System customer communications, including PIBs, Clinical Use Models, and field notifications
- Support the development of scientific presentations and draft clinical abstracts and publications for OCS Kidney users
Other Surgical and Strategic Tasks
- Participate in all 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 TransMedics duties as assigned
JOB REQUIREMENTS:- MD with advanced surgical training in abdominal organ transplantation
- 7+ years of independent surgical experience including abdominal organ procurement
- Upholds the highest moral and ethical standards
- Proven leader with the ability to build, manage, and develop teams while fostering a strong culture of engagement and accountability
- Exceptional customer-facing skills, with a demonstrated ability to engage effectively with clinical staff at sites and serve as a strong advocate for the OCS platform
- Ability to lead teams calmly and decisively, with clear direction, in time-sensitive, mission-critical environments
- Exceptional interpersonal and communication skills, and ability to communicate effectively with internal teams and clinical sites at all levels of the organization
- Detail-oriented, highly organized, hands-on self-starter
- Proven ability to collaborate effectively across functions and at all levels of the company
- Proven 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
How success is measured
- Timely delivery of results and executes corporate goals is paramount
- Builds a high-performing team and strong bench of talent accountable for day-to-day execution of the program's critical tasks
- 360-degree feedback from peers, direct reports, managers, and external clinical users and collaborators
- Maintains a calm, composed demeanor under pressure
- Provides the highest quality surgical service and maintains surgical availability to meet mission demand
- Maintains zero tolerance for ethical, moral, or interpersonal misconduct with peers
Working conditions
Executive 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. 
