Clinical Research Manager (Principal Clinical Research Scientist) - Medical Device/Pharmaceutical
Location:
Somerville , New Jersey
Posted:
April 02, 2017
Reference:
9082161021-en-us

The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a, Clinical Research Manager located in Somerville, NJ. 

 

The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies.  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. Operating on behalf of the Medical Device Group, this Clinical Research Manager (position officially title Principal Research Scientist) will have strong scientific and global medical device expertise to provide insights and strategic direction to develop innovative evidence generation (EGS) and dissemination strategies ( EDS) for New Product Development (NPD) and Life-Cycle Management ( LCM) projects for Ethicon products

 
 
OVERALL RESPONSIBILITIES:
 
  • Lead in study design discussions to develop appropriate clinical trials to meet the NPD / LCM as needed
  • Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts
  • 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, Regulatory Affairs, Health Economics& Market Access, R&D, ensuring cross- functional alignment
  • Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and Biostats and Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments in compliance with all applicable regulations and company procedures
  • 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
  • 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, including during sponsor regulatory inspections
  • Responsible for team’s interface and collaboration with key opinion leaders, investigators, clinical institutions, Regulatory Agencies, societies, associations
  • Foster strong relationships with external stakeholders to shape and influence relevant policies
  • Be a subject matter expert in the development of clinical evidence therapeutic areas of interest
  • 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;
  • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
  • Experience in effective management of project budget processes
  • Ability to apply understanding to help define and shape clinical evidence strategies 


Qualifications
  • Bachelor’s degree in Biological Science or related discipline is required with 8 years of leadership experience within clinical research OR 6 years with a Masters OR 3 years with a Ph.D.
  • Ability to influence, shape and lead without direct reporting authority is required
  • Comprehensive understanding of clinical trial regulations across multiple regions is preferred
  • A successful track record of fostering strong relationships with external stakeholders to shape and influence relevant policies are preferred
  • Ability to 20% international and domestic

Johnson & Johnson is an equal opportunity employer


Primary Location
United States-New Jersey-Somerville
Organization
Ethicon Inc. (6045)
Job Function
Clinical Research non-MD
Requisition ID
9082161021

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