Director, Global Medical Safety, VitRet/Glaucoma

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, Global Medical Safety VitRet/Glaucoma, will serve as the medical and scientific safety leader for assigned Alcon projects or products. This role will be on-site in our Fort Worth, Texas location.
The position is primarily responsible for:

• Responsible for safety management of assigned products in clinical development through post-approval lifecycle.
• Responsible for key internal Alcon safety documents. Develop and update these documents with new or changes in product safety information. Ensure accurate and high-quality outputs.
• Responsible for overall signal detection, monitoring, evaluation, and appropriate management of safety information from relevant line functions, clinical studies, post-marketing experience, literature, and other sources. Lead the Safety governance boards related to assigned platforms. Provide medical safety review and approval of pre and post-market documents (e.g., CER, CSR, etc.) as Clinical / Medical Expert.
• Responsible for post-market surveillance plans, periodic safety updates, product labelling and related documents, including safety information to support product claims.
• Responsible for health hazard assessments and responses to inquiries from health authorities, health care professionals, and legal on safety issues. Prepare safety data for health authority review boards.
• Provide expert medical and scientific guidance to local affiliates on safety issues.
• Provide expert medical and scientific input to the clinical development program for assigned projects/brands.
• Provide integrated safety input into all regulatory documents required during active product development.
• Prepare and present franchise or brand safety issues to Alcon Boards and other meetings.
• Provide guidance on safety topics, initiate and maintain productive cross-functional collaborations internally with R&D colleagues, business partners, and externally.
• Ensure support for business development and licensing activities, regulatory inspections/audits, and market action activities.
• Foster an innovative culture, ensuring a collaborative, high performing safety group.
• Provide resource coverage and support project activities across therapeutic areas to ensure timely safety deliverables, when needed.

What You'll Bring to Alcon:

• Bachelor's Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs).
• The ability to fluently read, write, understand and communicate in English.
• 10 Years of Relevant Experience.

Preferred Qualifications:

• Optometrist or Ophthalmologist (MD or DO)
• Experience in a surgical setting.
• Ophthalmic medical device industry experience in related field (e.g. Medical Safety, Clinical R&D, etc.).

How You Can Thrive at Alcon:

• 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 10%
• Relocation - Yes
• Sponsorship - No

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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.comand let us know the nature of your request and your contact information.