Johnson & Johnson is currently seeking a Head, Clinical Science (J&J MedTech Vision) to join our team located Jacksonville, FL.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
The Head, Clinical Science directs the development of the worldwide clinical investigational plans for all JJV products, including: Surgical/Implant, Refractive Lasers/Equipment, and Vision Care products, consistent with corporate objectives. Studies done by this department must be in compliance with appropriate international guidelines and regulatory agencies. Responsible for the activities of the JJSV and JJVC Clinical Science Departments.
Operating on behalf of Johnson & Johnson MedTech Vision, this role is accountable to lead the Clinical Sciences R&D organization, supporting the global portfolio, partnering with our Platform Leaders, Clinical Operations team, other R&D colleagues, Regulatory, Supply Chain, Quality and other key stakeholders. Additionally, to provide deep clinical and scientific insight that accelerates innovation, value and safety for patients and customers everywhere through strong leadership and partnership with the following innovation and business partners: R&D, Global Strategic Marketing, New Business Development, External Innovation, Regulatory, Quality and Supply Chain.
Key Responsibilities:
- Responsible for development of the overall strategy for the worldwide clinical investigational plans for all JJV clinical studies intended to support registration, research release and market support. Develop and execute global integrated strategies for evidence generation for new and existing products in order to support innovation, regulatory approval/clearance, health technology assessment, customer access, medical safety and post-marketing.
- Responsible for the clinical studies, from the early phases of protocol design to data analysis, interpretation and final report writing. Accountable for the overall summary of safety effectiveness for registration packages. Advances clinical science through rigorous scientific approaches and leveraging data science capabilities where appropriate.
- Responsible for Research Compliance by maintaining Good Clinical Research Practices and SOPs in compliance with ISO/ANSI, FDA and other regulatory guidelines.
- Provides technical consultations to other department for registration purposes, acquisitions, Marketing, Legal and Sales Training.
- Responsible for annual budgets for Clinical Science (Santa Ana, Milpitas, Jacksonville & Europe and Japan), Biostatistics and Technical and Scientific Support Cost Centers.
- Responsible for representing JJV as the corporate clinical expert in Surgical and Vision Care areas to outside companies, regulatory agencies, professionals and professional societies in order to present JJV's image as an ethical, research-oriented company.
- Hires, trains, and ensures retention of high-caliber individuals in the Clinical Science organization.
- Responsible for promoting JJV's image as a high quality, ethical, research-oriented organization to the ophthalmic professions through productive collaborations and strong podium/publication record. This is accomplished by representation at professional meetings, high level publications and interaction with professional societies and schools.
Qualifications
• Advanced Degree (Phd, MD, OD)
• A minimum of 10 years of related experience
• A minimum of 8 years of related scientific/technical experience, including leadership/management role
• Industry experience leading Clinical/R&D teams in a highly regulated, commercial medical device business
• A minimum of 5 years of people management-related experience
• Demonstrated expertise and success in building Clinical Research or Research & Development teams and leaders to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas
• Experience within ophthalmology and/or optometry area (IOL development, contact lens, etc)
The anticipated base pay range for this position is 187000 to 322000.