Johnson & Johnson Careers
Principal Clinical Research Scientist
Santa Ana, California
Clinical Research non-MD
Requisition ID: 0044180819
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Principle Clinical Research Scientist, in Santa Ana, CA.
JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.
Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
Operating on behalf of the Medical Device Group, this leader will have deep scientific expertise to provide insights and strategic direction, developing evidence generation / dissemination strategies for transformational / complex programs;
Responsible for Clinical R&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 MD 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 etc
- Contribute 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, etc;
- Foster strong relationships with external stakeholders to shape and influence relevant policies, etc
- Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access
Functional and Technical Competencies:
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;
Experience in effective management of project budget processes
Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, Deliver as noted below.
Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
Shape – build strong relationships with external stakeholders to shape and influence relevant policies
Lead – continually develop expertise to provide strategic and scientific clinical research capability
Deliver – ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Performs other related duties as required.
A Bachelor’s degree in Biological Science or related discipline.
An advanced degree in Ophthalmology, Optometry and PhD in related field is preferable.
A minimum of 8 years of experience in Clinical Research is required.
United States-California-Santa Ana
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