Programme Manager; R&D

Organ Ox is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. Organ Ox is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia.

It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

The Programme Manager (R&D) is accountable for the successful delivery of one or more strategic New Product Development (NPD) programmes.

The role provides end-to-end leadership across the product development lifecycle, integrating technical development, regulatory activities, quality requirements, manufacturing readiness, commercial objectives and organisational priorities into a single executable programme.

Working across Research & Development, Regulatory Affairs, Quality Assurance, Operations, Supply Chain, Clinical, Commercial and Executive Leadership teams, the R&D Programme Manager will drive programme execution, governance, risk management, resource planning and stakeholder alignment to achieve programme objectives.

This role requires a highly experienced programme leader with a proven track record of delivering complex medical device development programmes within regulated environments.

This is an on-site role in Oxford with flexibility.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Under direction from the Director, PMO the Programme Manager (R&D) will be responsible for:

• Delivery of assigned New Product Development programmes to agreed scope, quality, cost and timeline.
• Development and maintenance of integrated programme plans.
• Programme governance and stage-gate management.
• Programme budget forecasting and financial control.
• Cross-functional resource planning and prioritisation.
• Executive stakeholder management and reporting.
• Identification and management of programme risks, dependencies and opportunities.
• Ensuring compliance with Organ Ox Quality Management System requirements and applicable regulatory standards.
• Drive transition from product development, scale-up, regulatory approval and commercial launch.

• Lead strategic New Product Development programmes from concept through development, verification, validation, regulatory approval, manufacturing transfer and product launch.
• Develop and maintain integrated programme plans covering all programme work streams.
• Define programme objectives, success criteria, milestones and critical dependencies.
• Ensure programme activities remain aligned to organisational strategy and product roadmap.
• Drive programme execution through proactive leadership, coordination and decision‑making.
• Establish / maintain programme governance structures, reviews and reporting mechanisms.
• Facilitate programme steering committees and executive review meetings.
• Uphold programme management standards and best practices.

• Lead and coordinate…