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Senior Clinical Project Lead

Alcon
Fort Worth, United Statesfull_timeVerifiedPosted 1 Nov 2023

About the role

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. As a Senior Clinical Project Lead you will be responsible for overseeing, designing, planning and developing clinical evaluation research studies in Fort Worth, Texas. In this role, a typical day will include:

  • Represents the Clinical R&D function at the Project core team and acts as the single point of contact for the Project Head on all clinical activities/functions.
  • Oversees all aspects of Clinical R&D related to the project's stage in the R&D portfolio.
  • Leads clinical sub-teams on clinical strategy, designs, executes and participates in clinical trial teams to oversee conduct and reporting.
  • Designs and provides oversight of clinical research programs in the assigned therapeutic area(s)
  • Builds relationships with key opinion leaders and applies their input to enhance study design and protocols.
  • Confirms that clinical research program design meets scientific objectives and is aligned with commercial needs.
  • Serves as a medical/scientific consultant to marketing or research project teams and government regulatory agencies.
  • Establishes the criterion essential for determining the safety, efficacy, and value of products in the surgical franchise.
  • Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
  • Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application.
  • Collaborates and serves as the key clinical partner with regulatory team on 510(k)/PMA submissions, Q-Sub meetings and other regulatory submissions for the project.
  • Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
  • May be responsible for clinical supply operations, site and vendor selection.
  • Conducts post marketing studies, life cycle management and training of customer facing medical affairs associates worldwide.

Preferred Qualifications:

  • Degree in Optometry/Ophthalmology/Vision Science
  • Experience in writing clinical study protocols.
  • Experience in planning, conducting, and reporting clinical research in vision science.
  • Experience in clinical trials regulations example, GCP, ISO standards.

WHAT YOU'LL BRING TO ALCON:

Key Requirements/Minimum Qualifications:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
  • The ability to fluently read, write, understand, and communicate in English.
  • 7 Years of Relevant Experience
  • 5 Years of Demonstrated Leadership

How You Can Thrive at Alcon:

  • Benefit from working in a highly collaborative environment.
  • 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!
  • Travel Requirements: up to 20%
  • Relocation assistance: Yes
  • Sponsorship available: No

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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

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Company

Alcon

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