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Associate Director, Clinical - Neurovascular
Clinical Research non-MD
Requisition ID: 6970180323
Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Clinical (Neurovascular) to be located in Irvine, Ca to support our neurovascular business.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
CERENOVUS is a global leader in neurovascular care. Offering a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke, CERENOVUS is committed to changing the trajectory of stroke.
Operating on behalf of the Medical Device Group, this leader will lead a team of clinical research professionals to develop evidence generation / dissemination strategies (EGS/EDS) for multiple and / or complex projects;
The Associate Director will:
• Be responsible for Clinical activities for multiple and / or complex projects, including:
• Lead team of clinical research professionals to develop and deliver appropriate clinical evidence generation and dissemination strategies to support products within Cerenovus, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access), ensuring cross- functional alignment;
• Account for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and Biostatistics and Data Management 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 clinical leads and other strategically important countries/regions in the development of the clinical evidence generation and dissemination strategies;
• Lead team of clinical research scientists to design appropriate clinical trials to meet the product development needs;
• Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on clinical evidence dissemination strategy, including clinical study reports, abstracts, manuscripts, etc
• 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 extension, etc, including during sponsor regulatory inspections;
• Be 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.
• Possess 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;
• Lead a team of scientists to provide strategic and scientific clinical research input across product development projects;
• Deliver clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Understand clinical trial regulations across multiple regions;
• Collaborate across different functional areas to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;
• Masters’ degree in Biological Science or related discipline is required.
• A minimum of 8 years related scientific / technical experience, including leadership / management role within clinical research is required
• A minimum of 2 years people management-related experience is required.
• Experience including involvement with investigational device exemption (IDE) trials is required.
• Knowledge and experience in neurovascular is strongly preferred.
• Experience in effective management of project budget processes is preferred.
• Travel of up to 20% is required, primarily domestic.
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