Vice President Clinical Affairs
About the company
An innovative, Europe-based medical technology company is developing a novel orthopaedics implant designed to support the treatment of focal cartilage defects in the knee. The company is entering a pivotal clinical phase, with a US-focused clinical programme playing a central role in its regulatory and commercial ambitions.
This is an opportunity to lead the end-to-end sponsor-side management of a pivotal international clinical programme.
About the role
You will lead the CRO and other clinical partners, build strong relationships with investigators and sites, and ensure the programme delivers against timelines, budget, quality and risk. The role also offers the opportunity to shape the company's broader clinical capabilities as it grows.
The position reports directly to the CEO and provides exposure to senior leadership, the board, clinical advisers and leading orthopaedic investigators.
It is a remote role but requires travel.
About you
Key requirements:
- Significant clinical operations or clinical affairs experience within orthopaedic implantable medical devices.
- Direct operational leadership of high-risk medical device clinical trials.
- Strong knowledge of the US and EU investigational-device environment, including meaningful IDE and PMA experience.
- Proven sponsor-side CRO and vendor management experience, with accountability for budgets, performance, deliverables and risks.
- Hands-on experience across site selection, study start-up, enrolment, monitoring oversight, issue resolution and close-out.
- Demonstrated ability to build strong, productive relationships with orthopaedic investigators and clinical research sites.
- Experience managing multi-site, multinational clinical programmes, ideally pivotal or PMA-supporting studies.
- Experience in cartilage repair, knee preservation, sports medicine, orthobiologics or regenerative medicine would be highly valued.
- Experience in a start-up or growth-stage MedTech environment is strongly preferred
- Strong judgement, resilience and ability to operate hands-on and independently in a lean organisation.
- Excellent communication skills with clinicians, technical experts and senior business stakeholders.
- Availability for regular US travel and periodic international travel to Europe.