Total 4 Director/C-Level Science / R&D / Research job vacancies in Fort Myers, FL

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 an Associate Director, Pharmaceutical Programming in Fort Worth, TX, you will act as key leader responsible for independently managing activities and resources to ensure quality, timely and efficient execution of all statistical programming aspects of global studies and projects in a franchise or a therapeutic area (TA) and act as the strategic point of contact for Franchise, TA, Project and Trial Statisticians for the same franchise or TA

Major Accountabilities

• Provide leadership to achieve goals aligned with franchise and organizational objectives

• Serves as statistical programming expert within a franchise or TA to the broader Alcon

• Manage global associates in different Alcon locations including but not limited to Alcon Global Services centers worldwide

• Responsible for recruitment, onboarding, professional development, training, mentoring, retaining, and performance management of assigned programmers

• Understand SP deliverables, customer expectations and resource requirements. Prioritize tasks, assign resources, and manage plan to optimize resources.

• Forecast short-term and long-term demand for resources

• Generate status reports and metrics

• Lead statistical programming activities as Project Programmer or Trial Programmer as needed

• Build and maintain effective working relationships with leadership and relevant cross-functional teams. Effectively communicate the status of deliverables, changes to plan, risks, and proposed mitigation strategy

• Lead development of SP standards and processes, knowledge sharing, and other tasks as assigned

​Key Performance Indicators

• Achievement of goals aligned with franchise and organizational objectives

• Quality and timeliness of all deliverables within Franchise or TA

• Effectiveness in developing, mentoring, retaining, and managing performance growth and rewards of assigned programmers

• Accuracy of resource estimation and efficiency in resource utilization

• Effectiveness in representing SP in relevant teams and facilitating cross-functional collaboration

• Development of standards and processes that improve quality, timeliness and/or efficiency of deliverables

• Compliance with internal and external standards as measured by audit findings

​Impact in the Organization

• Timely and high-quality SP deliverables. Delays and errors in deliverables may impede submissions or other product developments and subsequent revenue loss to the company

• Efficient programming leading to quality submissions, and reduced time and costs for development and registration

• Ensuring external quality reputation of Alcon with Health Authorities

Competency Profile

• Strong leadership, collaboration, and organizational skills with proven ability to successfully manage numerous, simultaneous activities and meet deadlines

• Strong SAS programming skills including development and use of macros and experience with R programming would be helpful

• Extensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activities

• Extensive experience in developing programming dataset specifications

• Good working knowledge of statistical concepts

• Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, ICH) and industry standards such as CDISC

• Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions

• Excellent written and oral communication

• Good skills in interviewing, mentoring, coaching, knowledge management and best practice sharing

• Pharmaceutical programming experience, 7 years of relevant programming experience, 3 years of proven ability to lead statistical programming activities as a Project Programmer and 3 years of management experience

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 

• Work hours: M-F, standard

• Travel Requirements: 5-10%

• Relocation assistance: yes

• Sponsorship available: yes    

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ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

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.

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 Director of Regulatory Operations, Labeling supporting US Dev Global Regulatory Affairs Operations, you will be trusted to drive Global Regulatory strategy to facilitate market success and is responsible for ensuring close collaboration with key collaborators at Fort Worth, TX.

In this role, a typical day will include:

• Direct submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports
• Stay ahead of changing global labeling requirements and communicate those changes within GRA and to cross-functional colleagues.
• Responsible for Corporate RA SOPs regarding labeling and sets boundaries and/or coordinate with RA affiliates on local labeling procedures. Own RA Labeling process and current project work under project Clear.
• Represent RA in the Labeling Change Review Board.
• Be the counterpart to the GSC Labeling Head and be involved with cross-functional decisions and critical issue pathways.
• Share responsibility with GRA strategists for decision-making on bundling and/or deferring proposed label changes, and/or deviations to label requirements.
• Coordinate and lead close partnership with the GRA team and support a broad portfolio for Labeling.
• Anticipate and provide assessments of changing regulations and mentorship and identify any required changes to internal Labeling policies and processes as the Labeling RA SME.
• Develop and lead global Labeling regulatory strategies to improve the value of the portfolio.

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
• 6 Years of Demonstrated Leadership
• Work hours: M-F
• Travel Requirements: up to 20%
• Relocation assistance: Yes
• Sponsorship available: No

PREFERRED QUALIFICATIONS/SKILLS/EXPEREINCE

• Background in Regulatory Affairs and Labeling
• Ability to excel in a matrixed environment and influence internal and external partners to achieve desired business outcomes
• Strong writing skills and editing in the form of high-quality regulatory submission documents

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and findings 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 for exempt associates, PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

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.

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 Director, Global Medical Safety you serve as the medical and scientific safety leader for assigned Alcon projects or products. You will be trusted to work on the integration, analysis, and interpretation of safety information from clinical development through post-approval lifecycle. In this role, located in Fort Worth, Texas, a typical day will include:

• 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 Management Team (SMT).
• 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 medical and scientific guidance to local affiliates on safety issues.
• Provide medical and scientific input to the clinical development program for assigned projects/brands. This includes input to Data Safety Monitoring Board and Safety Adjudication Committee activities, as required.
• Provide integrated safety input into all regulatory documents required during active product development.
• Ensure timely communication of safety information to Qualified Person for Pharmacovigilance for applicable product portfolio.
• Prepare and present 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 SMT.
• Provide resource coverage and support project activities across therapeutic areas to ensure timely safety deliverables, when needed.
• May function as a deputy for Head, Medical Safety and Compliance for assigned activities.

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 Proven Experience
• 6 Years of Proven Leadership

Preferred Qualifications

• M.D./D.O.
• PhD.

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: 10%
• Relocation assistance: Yes
• Sponsorship available: No

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

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.

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 Director, Global Medical Safety – Surgical you serve as the medical and scientific safety leader for assigned Alcon projects or products. You will be trusted to work on the integration, analysis, and interpretation of safety information from clinical development through post-approval lifecycle. In this role, located in Fort Worth, Texas, a typical day will include:

• 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 Management Team (SMT).
• Responsible for post-market surveillance plans, periodic safety updates, product labeling 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 medical and scientific guidance to local affiliates on safety issues.
• Provide medical and scientific input to the clinical development program for assigned projects/brands. This includes input to Data Safety Monitoring Board and Safety Adjudication Committee activities, as required.
• Provide integrated safety input into all regulatory documents required during active product development.
• Ensure timely communication of safety information to Qualified Person for Pharmacovigilance for applicable product portfolio.
• Prepare and present 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 SMT.
• Provide resource coverage and support project activities across therapeutic areas to ensure timely safety deliverables, when needed.
• May function as a deputy for Head, Medical Safety and Compliance for assigned activities.

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 Proven Experience
• 6 Years of Proven Leadership

• Preferred Qualifications
• M.D./D.O.
• PhD.

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: 10%
• 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.