Principal Clinical Research Scientist

Company: Johnson & Johnson
Location: Santa Ana
Posted on: September 3, 2020

Job Description:

Job DescriptionJohnson & 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.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.Position summaryYou will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects;Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;Comprehensive understanding of clinical trial regulations across multiple regions;Ability to lead teams to deliver critical milestones, including complex projects;Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;Leadership requirement - ability to influence, shape and lead without direct reporting authority;Change agent in team development and progression;Experience in effective management of project budget processesEssential ResponsibilitiesResponsible for Clinical R&D (CR&D) activities for assigned projects, including:Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment;Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);Ensure input and strong alignment from key regional Medical Device CR&D leads and other strategically important countries/regions in the development of the EGS / EDS;Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs;Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etcContribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;Responsible for team's interface and collaboration with key opinion leaders, investigators, IRB's/EC's, Regulatory Agencies, societies, associations,Foster strong relationships with external stakeholders to shape and influence relevant policies,Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursementQualificationsA Bachelor's degree in Biological Science or related discipline is required.Advanced degree in Ophthalmology, Optometry and PhD in related field is preferable.A minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research is requiredAbility to support 25% domestic and international travel is required.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.

Keywords: Johnson & Johnson, Santa Ana , Principal Clinical Research Scientist, Healthcare , Santa Ana, California