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.
