Sr. Director Post-Market Evidence

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 experienc