Johnson & Johnson Careers
SR PRINCIPAL CLINICAL SCIENTIST
Requisition ID: 9892190731
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Principal Clinical Research, to be located in Santa Ana, CA JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring fr the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio.
§ Responsible for Clinical R&D activities for multiple and / or complex projects
§ Design, conduct, and interpret research studies in support of new product introduction.
§ Contribute in the organization or direction of experiments through the development of methodologies.
§ Review, analyze, and interpret data, and draw conclusions which lead to planning further research.
§ Summarize and interpret clinical study data in technical reports.
§ Act as a recognized as a subject matter expert on clinical research mainly on JJV products.
§ May oversee/lead a team of 1 or more clinical science associates
§ Adhere to environmental policy, procedures, and support department environmental objectives. Engages in Credo-based decision-making.
§ Lead the development and deliver appropriate Global Evidence Generation and Dissemination Strategies to support New Product Development and Life-Cycle Management for transformational / complex programs.
§ Provide input to and execute clinical strategies in support of NPD, including trial concepts, design, execution, data analysis and interpretation, as well as clinical study reporting, in collaboration with Clinical Operations.
§ Partner with R&D personnel (technical project manager, designers) global marketing, marketing research and regional partners to complete development projects that meet the needs of all partners.
§ Communicate data and conclusions using appropriate interpretation and understanding of clinical outcomes related to product performance.
§ Partner externally to develop solutions to project problems and clinical research approaches including development of new test methods.
§ Build and sustain a learning environment to develop and share best practices throughout the organization.
§ Perform other related duties as assigned by management.
§ Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BD teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP)
§ Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs
§ Lead in the appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs, etc.
§ Act as the subject matter expert (SME) for product-specific and state of the art literature reviews, particularly for clinical evaluations
§ Lead the clinical aspects of labelling review for on-market products undergoing transition to EU MDR with respect to sufficient clinical evidence
§ Responsible for product Global Clinical Plans (GCPs), including PMCF plans for products intended for EU under EU MDR and leading such PMCF planning activities
§ Lead 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 and reimbursement
POSITION DUTIES & RESPONSIBILITIES:
Functional and Technical Competencies:
· Deep expertise in 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 lead cross-functional teams to provide strategic and scientific clinical research input across NPD and LCM projects, including complex / 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;
· 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 progression;
· Experience in effective management of project budget processes
· Through transparent leadership, this individual will support shaping a high-performing team with a global culture;
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 – continue to develop expertise in the development of strategic and scientific clinical research strategies for complex programs
· 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.
· Doctoral Degree-Optometry, PhD in Vision Sciences, or MD with specialty in Ophthalmology is required.
· Post-graduate degree or residency preferred.
· A minimum of 8 -10 years related scientific / technical experience in clinical research of vision science areas, basic science research or patient care is required including leadership / management role.
· Comprehensive knowledge, understanding and application of principles, concepts and practices of clinical research is required
· Ability to interpret and communicate technical and scientific data to clinical and non-clinical audiences is required
· Strong organizational, analytical, communication and interpersonal skills are required
· Demonstrated ability to build successful relationships with key opinion leaders and investigators globally is preferred
· Prior people management experience with coaching and mentoring skills to develop others is preferred
· This position may require approximately 15% travel, both domestic and international.
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
United States-California-Santa Ana-
Johnson & Johnson Surgical Vision, Inc (6234)
Clinical Research MD