Director, Clinical Research-Instrumentation

Alcon Research•Lake Forest, CA

About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. The Director of Clinical Research - Instrumentation role is pivotal in driving forward our mission of advancing eye care through development of next generation products. This position is located in Lake Forest, CA. A typical day will include: Leading and running R&D Clinical Project Leads (GJFA between 4-6) to develop high quality global medical evidence plans, pre & post registration (Phase I – IV) in all stages of the medical device development, for the specific product area(s) in the device pipeline in full alignment with the Franchise imperatives 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. Activities include but not limited to, understanding, and evaluating available clinical data (on the specific portfolio), reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities 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, report study progress and issues with their resolution plan. 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.

Requirements

Bachelor’s Degree or equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; Bach. +10yrs; M.S.+7 yrs; PhD+6 yrs)
The ability to fluently read, write, understand and communicate in English
10 Years of Relevant Experience
Travel Requirements: 30%

Nice To Haves

Refractive experience
Product launch experience

Responsibilities

Leading and running R&D Clinical Project Leads (GJFA between 4-6) to develop high quality global medical evidence plans, pre & post registration (Phase I – IV) in all stages of the medical device development, for the specific product area(s) in the device pipeline in full alignment with the Franchise imperatives
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. Activities include but not limited to, understanding, and evaluating available clinical data (on the specific portfolio), reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities
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, report study progress and issues with their resolution plan.
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.