Interim Director of Clinical Affairs (Medtech)
Our Client is a well-funded medtech company that has made tremendous progress over the past 2-3 years and is now on the verge of a significant expansion to its clinical programme. The exciting technology that underpins the product development and the data available so far would suggest the promise of significantly reduced mortality and morbidity for many patients.
The need exists for an Interim Director of Clinical Affairs, with responsibility for the planning, implementation and management of the clinical activity, including initial FDA and CE clinical trials, clinical studies and support of key opinion leaders (KOL’s).
The successful candidate will be expected to provide major input into the development of clinical strategy, development of protocols that meet all applicable regulatory requirements, product claim support and market introduction requirements, be highly active in the identification, appointment and management of supporting CRO’s and generally be responsible for delivery of the overall clinical programme in a timely and financially-responsible manner.
The assignment will be located in the UK, although travel will be expected to a number of European countries, and possibly the US. The role reports directly to the company’s CEO.
Expected duration of assignment is 9 months, starting at 2-3 days per week, rising to 4/5 days per week after 4 months. The possibility of a subsequent transition to a position of permanent employment does exist for the right candidate.
Candidates must have significant experience with medical device clinical trials and of CE and FDA submissions. Initiative, leadership and organisational management skills are essential.
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