The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Clinical R&D Leader, to support several platforms within the Ethicon Franchise, primarily based out of the Cincinnati R&D campus. This leader will be accountable for the development and execution of successful global clinical programs delivering key evidence needs on time and on budget. This role requires working closely with Clinical R&D Operations and BSDM to ensure delivery of projects. Candidates should possess a track record of success with prior experience in the industry, demonstrated skills and strong leadership attributes
The MD CR&D COE is being created to support all clinical activities across all business units within the Global Orthopaedics and Global Surgery Groups. The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management. All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle. Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.
Clinical R&D Franchise provides clinical science expertise that drives new product innovation and life-cycle management to develop clinical evidence generation strategies that support the value proposition to all stakeholders (5Ps). This group insures the dissemination of clinical evidence to support the portfolio and advance scientific understanding.
Clinical R&D Biostatistics and Data Management (BSDM) has primary responsibility for statistical aspects of trial design, data management, and data analyses to deliver scientifically valid, efficient and cost effective clinical study analytics.
Clinical R&D Operations has primary responsibility for the successful execution of the clinical programs from study planning to closeout. Clinical R&D Operations insures projects are delivered on time, within budget and in compliance to all applicable regulations and company standards, to fulfill the evidentiary needs to support the portfolio and business success.
Operating on behalf of the Enterprise, this leader will be accountable to lead a team of highly effective clinical research scientists for the Endo-mechanical, Energy, Robotic Platforms, and the Metabolic Specialty, and, through transparent leadership, develop a high-performing team with a global culture. This individual will report to the VP, Ethicon, MD CR&D COE and will be part of the Ethicon Franchise CR&D leadership team.
Principal Duties and Responsibilities; This individual is accountable for all Clinical R&D activities for Cincinnati based projects, Endo-mechanical, Energy, Robotic Platforms, and the Metabolic Specialty, including:Serving as the CR&D representative on the platform governance / innovation committees, provide critical and technical expertise in portfolio prioritization, including assessment of potential acquisition opportunities, etc to shape business strategy. Build and develop talent to provide strategic and scientific clinical research capability across assigned platforms; lead team of clinical research scientists to develop appropriate Global Evidence Generation and Dissemination Strategies (EGS / EDS) to support New Product Development and Life-Cycle Management) within the assigned platforms, with collaborative relationships with all relevant partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, G-HEMA,R&D etc), ensuring cross- functional alignment; ensure input and strong alignment from China and/or Japan MD&D CR&D leads and other strategically important countries/regions in the development of the EGS / EDS; ensure strong alignment with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments; Interact with regulatory agencies / notified bodies to support review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections; accountable 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.
Qualifications
To meet requirements; a Bachelor’s degree in Biological Science or related discipline, with a minimum of 15 years related scientific / technical experience, including leadership / management role within Clinical Research for at least 8 years. This individual must possess strong leadership with the ability to influence, shape and lead, acting as a change agent in organizational progression to foster a highly effective team with a global mindset. Key requirements for this role are: a thorough understanding of clinical research science and processes along with an extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations; ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across NPD and LCM 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 Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.).
The location of this position will be Cincinnati, OH and may require up to 50% travel, national and international.
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