Director Clinical Operations

Opportunity for a Director of Clinical Operations to join a high-growth medical device company at a critical inflection point.

The organisation is progressing a Class III product through clinical trials while, in parallel, preparing for commercial scale-up. They’re expanding their European clinical footprint and are hiring for a Director of Clinical Operations to help scale activity across Western Europe (UK, Netherlands, Spain, Germany).

Responsibilities:

• Drive study timelines, milestones, and deliverables to support overall Clinical objectives. Specifically own and deliver EU/UK enrolment targets for the pivotal clinical trial
• Responsible for prioritising and coordinating the clinical research studies in UK/Europe in accordance with internal SOPs and appropriate regulatory requirements (e.g. ISO 14155)
• Manage existing UK/Dublin clinical team members and oversee expansion of capabilities to support UK/EU clinical activities
• Partner closely with Regulatory to support EU/UK regulatory submissions (e.g., competent authority and ethics committee submissions)
• Manage the development of clinical research plans and protocols
• Manage clinical site selection process overseeing the assessment of sites

Requirements:

• Bachelor’s Degree in Biomedical Science or similar field
• 10 years’ experience in clinical environment, preferably in cardiovascular medical devices
• Randomised controlled trials for implantables
• Excellent analytical skills (advanced Excel) with very strong numeracy
• Exceptional attention to detail
• Excellent communicator with experience developing relationships with senior internal stakeholders to understand their requirements
• Well organised with experience working to deadlines. Ability to operate both strategically and tactically in a fast-paced environment
• Be able to travel within UK/EU up to ~25–50%

This is an opportunity to join a high potential scale up, in a remote capacity. Top of market salary & benefits package available.