Manager, Clinical Research
Cincinnati, OH, USA | Johnson & Johnson
Job Description:106 people have viewed this job
The Endomechanical platform in The Ethicon Franchise, a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Manager located in Cincinnati, Ohio and may require up to 25% of domestic and international travel.
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.
Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.
Operating on behalf of the Ethicon PCM (Preclinical, Clinical and Medical) team, this individual will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects. Responsible for Clinical R&D activities for assigned projects, including:
Develop and deliver appropriate Global EGS / EDS to support NPD and 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, Preclinical, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment;
Responsible for delivery of assigned clinical projects, through effective partnership, 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 in study design to develop appropriate clinical trials to meet the NPD / LCM needs;
Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc.
Contribute in 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;
A Bachelor’s degree in Biological Science or related discipline is required.
A minimum of 8 years experience with BS, 3-6 years with MS or 3 years with Ph.D with related scientific / technical experience, including leadership / management role within Clinical Research is required.
A demonstrated knowledge of medical device research is required.
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 is required.
Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects is required.
Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is required.
Comprehensive understanding of clinical trial regulations across multiple regions is required.
Ability to lead teams to deliver critical milestones, including complex projects is required.
Leadership requirement – ability to influence, shape and lead without direct reporting authority is required.
Change agent in team development and progression is required.
Ability to stay current with evolving innovative minimally-invasive device-based therapies, including disruptive technology and associated clinical data is required.
Ability to apply understanding to help define and shape clinical evidence strategies in the surgical space is required.
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.