Director, Clinical Research-Instrumentation

Alcon; United States; Remote; USD 178,000 - 268,000; Full time

Job summary

Alcon seeks a Director of Clinical Research - Instrumentation, pivotal in advancing eye care through innovative product development. In this role, you will lead clinical evaluation teams, ensure compliance with MDR regulations, and provide leadership in global medical evidence planning. The position, located in Lake Forest, CA, offers a robust benefits package, including relocation assistance.

Benefits

Health, life, and retirement benefits

Flexible time off

Relocation assistance

Growth and development opportunities

Qualifications

• 10 Years of Relevant Experience in clinical research.
• Proven ability to lead global clinical evaluation teams.
• Understanding of medical device development and regulatory frameworks.

Responsibilities

• Lead R&D Clinical Project Leads and manage global medical evidence plans.
• Oversee preparation of clinical evaluation plans and ensure compliance with regulations.
• Act as primary contact for clinical evaluation and lifecycle management.

Skills

Leadership

Clinical Evaluation

Regulatory Knowledge (MDR, MDCG)

Education

Bachelor’s Degree or equivalent

Job description

Job Description

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.

What you'll bring to Alcon:

• 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%
• Relocation assistance: Yes

Preferred Qualifications:

• Refractive experience
• Product launch experience

How you can thrive at Alcon:

• Collaborate with teammates to share standard processes and finding as work evolves.
• See your career like never before with focused growth and development opportunities.
• Join Alcon’s mission to provide outstanding innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off and much more.

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Total Rewards

Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here

Pay Range

$178,400.00 - $267,600.00

Pay Frequency

Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.