Programme Manager (R&D)

ABOUT ORGANOX:

OrganOx 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. OrganOx 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.

Position Summary

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.

Key Accountabilities

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 OrganOx Quality Management System requirements and applicable regulatory standards.
• Drive transition from product development, scale-up, regulatory approval and commercial launch.

Major Responsibilities

Programme Leadership

• 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 workstreams.
• 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.

Cross Functional Leadership

• Lead and coordinate multidisciplinary teams comprising:
• Build strong collaborative relationships across the organisation.
• Influence stakeholders without direct authority.
• Resolve competing priorities and resource conflicts.
• Foster accountability, transparency and high-performance team behaviours.

Product Development & Design Control

• Ensure programme delivery complies with applicable design control processes.
• Support development and maintenance of Design History Files (DHF).
• Ensure programme alignment with relevant standards to include (ISO 13485, ISO 14971, IEC 60601, MDR (EU) 2017/745, FDA Quality System requirements)
• OrganOx Quality Management System
• Support design reviews and stage-gate approvals.
• Collaborate closely with Quality and Regulatory teams to ensure programme readiness throughout the development lifecycle.

Planning, Resource & Portfolio Management

• Develop and maintain integrated programme schedules.
• Identify resource demand and capacity requirements across programme workstreams.
• Work with Functional Leaders to optimise resource allocation.
• Escalate resource constraints and recommend mitigation strategies.
• Monitor programme dependencies across the wider portfolio.
• Support portfolio planning and prioritisation activities within the PMO.

Risk & Issue Management

• Establish and maintain programme Risk/Issue Management logs.
• Identify programme risks, dependencies and assumptions.
• Lead mitigation planning and recovery actions.
• Escalate significant programme risks in a timely and transparent manner.
• Drive resolution of critical programme issues.

Financial Management

• Develop and maintain programme budgets and forecasts.
• Support business case development and investment reviews.
• Ensure effective financial governance throughout programme execution.

Stakeholder & Executive Communication

• Provide clear and concise programme reporting to senior leadership.
• Present programme status, risks, decisions and recommendations to Executive Leadership.
• Ensure effective communication across all programme workstreams.

Continuous Improvement

• Support development and continuous improvement of PMO processes, tools and governance.
• Capture and implement lessons learned.
• Promote a culture of delivery excellence and continuous improvement.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements

Skills & Experience

• Proven Project Management experience in Medical Devices, Pharmaceuticals or equivalent. Minimum 8-10 years programme and project management experience.
• Track record in managing medical device design and development projects, working within ISO 13485, IEC 60601, and risk management processes of ISO 14971 and projects in a safety-critical regulated industry.
• Excellent communication and leadership skills, commercially aware with the ability to negotiate with suppliers / multi-functional internal stakeholders and lead project impact assessments.
• Ability to lead and manage cross-functional project teams effectively.
• Good working knowledge of standard office, project management and engineering software.
• Excellent financial management skills with experience managing multiple project budgets simultaneously.
• Experience in the management of teams both face to face and remotely through appropriate collaboration platforms and project management systems.
• Positive “can do” attitude; identifies problems, provides/facilitates the creation of options and recommendations and uses initiative to drive solutions.
• Multitasker - be able to juggle priorities across multiple needs.
• Has a solution focused, pragmatic approach.
• Confident communicator with ability to tailor style and content to the needs of the audience.
• Developed emotional intelligence, remaining calm under pressure and takes ownership for delivering outcomes.
• Shows commitment to professional development; demonstrates enthusiasm, willingness and ability to learn new skills.
• Creates momentum and excitement around initiatives and new approaches.
• Ability to adapt to a fast-paced and dynamic environment.

Qualifications

• Degree level education preferably within an engineering or science discipline.
• Formal project management training from a recognized accreditation body (PMP, Agile, Prince2 etc.).

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.