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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub** **Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

_Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments._

_Are you passionate about improving and expanding the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at_ _https://www.jnj.com/medtech_

We are searching for the best talent to join our Vision team, as Senior Director Post Market Evidence Generation, located preferably in Jacksonville, FL, or in Irvine, CA.

Purpose:

You will report directly to the Vice President of Medical Affairs. This role will be accountable and responsible for driving and executing the MedTech Vision post market strategic evidence generation plans, from ideation to data dissemination, and start-up through execution, of post market clinical studies including company sponsored studies (CSS), investigator-initiated studies (IIS), collaborative studies. Additionally, this role with lead the claims substantiation teams to ensure that all technical and clinical claims substantiation processes and documentation align with the MedTech Vision Claims strategy.

You will be responsible for:

+ In close collaboration with Clinical/Medical/HEMA Leaders, identifies and ensures global strategies, resources and accountabilities are in place to achieve rapid, cost-effective, and well-executed clinical studies, delivering high quality clinical data to support Market Adoption, Regulatory, Market Access, and Reimbursement needs.

+ Lead the post market studies function and own the budget to deliver post market clinical studies (including company sponsored, investigator initiated and collaborative) within clinical / surgical research setting, on time, within budget and in compliance with SOPs and all applicable regulations, and requirements.

+ Provide internal communication to key stakeholders of important clinical data and events (inc. escalation of compliance issues and status reports) and project updates.

+ Understand business value and balance overall business objectives and functional needs.

+ Communicates with and supports management of vendors (CROs, etc.), as needed.

+ Ensure Regulatory body inspection preparation and readiness (including study documentation filing and maintenance appropriately and timely).

+ Ensure robust substantiation is documented for all MedTech Vision product claims.

+ Represents Vision on clinical and scientific matters as they relate to product messaging and claims, including in external contexts where claims are being challenged legally.

+ Participate in and or lead evidence generation reviews, protocol reviews and project core teams as needed and appropriate.

+ Develop innovative solutions for complex problems, risk management strategies, and resource allocation. Identify opportunities and lead the implementation of new clinical systems and processes.

+ Responsible for the training, performance management, and development of post-market study and claims substantiation teams.

Requirements:

+ Advanced degree (PhD in Life Science, PharmD, OD, MD)

+ Minimum 8+ years of relevant experience including global team leadership across multiple studies/programs.

+ At least 5 years of experience with departmental budget planning, tracking and control.

+ Up to 20% domestic and international travel

Preferred Requirements:

+ Medical device experience is strongly preferred.

_Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._

_Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via_ _https://www.jnj.com/contact-us/careers_ _and internal employees contact AskGS to be directed to your accommodation resource._

The anticipated base pay range for this position is :

The expected base pay range for this position is $246,500 to $333,500.

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits