Johnson & Johnson Careers
Senior Clinical Leader–Endomechanical, Energy & Torax
Clinical Research non-MD
Requisition ID: 0841180508
Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Senior Clinical Leader–Endomechanical, Energy & Torax located in Cincinnati, OH. This position will require up to 25% domestic and international travel.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Senior Clinical Leader–Endomechanical, Energy & Torax will be operating on behalf of the Franchise Integrated Medical, Clinical & Pre-Clinical (MCP) function, this leader will be accountable to develop evidence generation strategies for Platform(s)/Business Units, with respective Franchise.
He/She will be accountable for all Clinical R&D activities for the respective (s)/Business Units. Providing critical technical and strategic expertise in the assessment of new business development projects and opportunities identified through the Innovation Centers, including potential investment and acquisition opportunities, to shape business strategy; build and develop talent to provide deep strategic and scientific clinical research capability across assigned platforms.
The Senior Clinical Leader–Endomechanical, Energy & Torax may lead team of clinical research professionals to develop and deliver appropriate Global Evidence Generation and Dissemination Strategies (EGS / EDS) to support New Product Development (NPD) and Life-Cycle Management (LCM) within the assigned platforms, with collaborative relationships with all relevant R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment.
• Reports to the Integrated Leader (MCP) for the respective franchise
• Accountable for overall delivery of assigned clinical programs, 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 leads and other strategically important countries/regions in the development of the EGS / EDS
• Lead team of clinical research scientists to design appropriate clinical trials to meet the new product development and life-cycle needs
• Ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, etc
• Participate/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
• Foster strong relationships with external stakeholders to shape and influence relevant policies, etc.
• Partner with HEMA and MCP teams to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
• 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 build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across NPD and LCM projects
• 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
• Experience in effective management of platform budget processes
• A Bachelor’s degree in Biological Science or related discipline, with a minimum of 12 years related scientific/technical experience, including leadership/management role within Clinical Research for at least 8 years OR a PhD or Masters, with a minimum of 10 years related scientific/technical experience, with at least 6 years of management within a Clinical Research role is required
• People management experience is required for this role
• Proven track record in delivering clinical programs (specific to medical devices) within clinical/surgical research setting, on time, within budget and in compliance to SOPs and regulations is required
• Experience as a change agent managing global organizational progression is required
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD