Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Irvine

Description

Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Clinical Research to be located in Irvine, California to support our Medical Devices business. 
 
Johnson & Johnson Medical Device Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of 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. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands. 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. 
 
Operating on behalf of the Medical Device Group, The Associate Director, Clinical Research will:
Lead a team of clinical research professionals to develop evidence generation / dissemination strategies (EGS/EDS) for multiple and / or complex projects;
Responsible for Clinical R&D activities for multiple and / or complex projects, including:
Lead team of clinical research professionals  to develop and deliver appropriate Global EGS / EDS to support New Product Development and Life-Cycle Management (NPD & 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 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 MD CR&D 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 NPD / LCM needs;
Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including CSRs, CERs, 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 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
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 a team of scientists to provide 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 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

About the company

If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.

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