At Alcon, the business problem is to advance eye care through development of next generation products, and the Director of Clinical Research - Instrumentation role is pivotal in driving forward this mission.
Requirements
- MDR regulations
- MDCG regulations
- PMCF studies
- Clinical evaluation plans
- Clinical trial management
- Medical device development
- Global medical evidence plans
Responsibilities
- Leading and running R&D Clinical Project Leads to develop high quality global medical evidence plans, pre & post registration (Phase I – IV) in all stages of the medical device development
- Leading and running global clinical evaluation teams develop high quality clinical evaluation plans and document in full alignment with MDR regulations
- Having a good knowledge of MDR, MDCG regulations and ensure high quality, cost efficient PMCF studies are planned and conducted by the group
- Acting as the primary point of contact for the company on all aspects of clinical evaluation & Life Cycle Management
- Ensuring high-quality, scientifically-sound clinical protocols and related documents that produce clear, conclusive results
- Leading and handling the clinical trial aspect for project/program teams to ensure all trial results are met according to timelines, budget, quality standards and operational procedures
- Being accountable for medical/scientific review of clinical trial data, final analysis, and interpretation within clinical trial reports, publications, and internal/external oral and written presentations
Other
- Bachelor’s Degree or equivalent years of directly related experience
- 10 Years of Relevant Experience
- Travel Requirements: 30%
- Relocation assistance: Yes
- Ability to fluently read, write, understand and communicate in English
