Job Description

Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is recruiting for a Principal Clinical Research Scientist to be located in Santa Ana, CA or Remote located may be considered.

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life--to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

The Principal Clinical Research Scientist for the Surgical Vision platform is an expert in ophthalmology and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to doctors and their patients.

You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient.

Essential Responsibilities:

* Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs.
* Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle.
* Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.).
* Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
* Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies

Qualifications
* Bachelor's degree in a scientific field is required, advanced clinical degree is preferred (OD or MD, or equivalent)
* At least 6 or more years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required
* Direct experience in ophthalmic device clinical research and development is required
* Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
* Understand biostatistics as applied to study data is required
* Proficient with computers and software programs is required
* Able to break down sophisticated concepts into informative content, adjusting style, scope and detail as suited for the audience. is required
* Up to 20% domestic and international travel may be required.
* Authored scientific publications, posters, and/or paper presentations is preferred
* Understand MDR requirements and their application to premarket and CE marked products is preferred
* Advanced Excel to craft accurate and clear graphs/tables of complex data and analyses. Strong PowerPoint skills to build interesting and insightful presentations of technical content with an eye for aesthetic is preferred
* Experience with patient-reported outcomes and research questionnaire development is preferred
* Ability to navigate deftly around industry guidance (MDR, ANSI Z80, ISO 11979 series, etc.) with regard to clinical study design. is preferred

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

LI-JBROWN52

Primary Location
United States-California-Santa Ana-1700 E Saint Andrew Place
Other Locations
North America-United States
Organization
Johnson & Johnson Surgical Vision, Inc (6234)
Job Function
R&D;
Requisition ID
2105904198W