Medical Device Programme Lead

Job Title: Medical Device Programme Lead

Job Type: Full-time, Permanent Position

Location: West London, UK – Hybrid/Remote

Remuneration: Competitive salary and package

Cpl Life Sciences is partnering with a growing stealth-mode biotech at the heart of AI innovation and drug development. We are seeking an experienced Medical Device Programme Lead to take full ownership of a complex drug-device combination programme supporting late-stage clinical development. Operating as the sponsor-side lead, you will be responsible for driving programme strategy, coordinating external development and manufacturing partners, and ensuring the device remains on track to meet clinical, regulatory and commercial objectives.

This is a highly visible role within a lean organisation, offering significant ownership across device development, design control, clinical trial readiness and partner management. The successful candidate will act as the key interface between engineering, clinical, regulatory, quality and manufacturing teams while guiding the programme through critical development milestones. Experience with infusion, injection or fluid delivery systems is essential, while exposure to neurology, advanced therapies or complex combination products would be highly advantageous.

Key Responsibilities

• Own the end-to-end device programme, including timelines, risks, budgets and strategic decision-making.
• Lead external development, manufacturing and specialist partners to ensure deliverables are achieved.
• Drive design control activities, traceability, DHF management and regulatory submissions.
• Ensure clinical trial readiness, including device supply, site support and device deficiency management.
• Oversee software and digital elements where applicable, including SaMD and connected device technologies.

Essential Experience

• Proven experience leading complex medical device or combination product programmes within a sponsor environment.
• Strong background in infusion, injection or fluid delivery devices through development and clinical use.
• Demonstrated success managing external design, manufacturing and development partners.
• Experience supporting devices in clinical trials and working to critical study timelines.
• Strong working knowledge of ISO 13485, ISO 14971, design controls and combination product regulations.
• Comfortable operating with significant autonomy and accountability within a small, growing organisation.

Highly Desirable

• Infusion pump or connected device experience.
• Software as a Medical Device (IEC 62304) expertise.
• Neurology, neurosurgical or targeted drug delivery experience.
• Cell & Gene Therapy, AAV or advanced therapy programme exposure.
• Experience supporting AI-enabled or digitally connected medical devices.

For more information, please reach out to me at lucy.kirkaldy@cpl.com