.Johnson & Johnson is currently seeking a Head, Clinical Science (J&J MedTech Vision) to join our team located in Jacksonville, FL, Irvine, CA, or Milpitas, CA.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.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.
Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.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.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.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 departments 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