Head, Clinical Development Standards (Senior Director)
Location:
Hopewell Township , New Jersey
Posted:
April 02, 2017
Reference:
0000187K/2-en-us

Janssen Research & Development, LLC, a member the Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Head, Clinical Development Standards to be located at the Janssen campuses on the East Coast US (Titusville NJ, Raritan, NJ or Springhouse, PA applicable) OR Beerse, Belgium.       

                                                                      

The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. We recognize the impact of serious conditions on people's lives, and we aim to empower people through disease awareness, education and access to quality care.  Our research and development strategy focuses on identifying medical needs and harnessing the best science in the world, whether from our own laboratories or through strategic relationships and collaborations. We leverage our world-class discovery and development expertise and operational excellence to deliver innovative, effective solutions.

  • Reporting to the Head of Integrated Data Analytics & Reporting (IDAR), the job holder is accountable for leading all aspects of clinical development standards from collection to reporting. With a predominant focus on scientific, strategic and technical leadership, the Head, Clinical Development Standards will translate the standards strategy into a robust implementation plan, executing against the plan globally, and monitoring success through metrics and a robust governance model. 
  • To that end, the job holder will work across the organization and partner with relevant departments in Global Clinical Development Operations (GCDO) and outside GCDO such as, but not limited to, the various Therapeutic Areas, Quantitative Sciences and Regulatory Affairs. Additionally, the job holder will partner in cross sector initiatives pertaining to the wider implementation of clinical development standards.
  • The job holder will provide oversight and leadership to the Clinical Development Standards team, driving the enablement of efficient business processes through standards.
  • The Head, Clinical Development Standards will be responsible for leading a team in IDAR that is accountable for developing, deploying and maintaining Clinical Development Standards in support of the Janssen pharmaceutical portfolio of products specifically within Janssen R&D scope, driving data quality and consistency within and across line functions.
  • The Head, Clinical Development Standards will champion development and implementation of Clinical Development Standards, ensuring effective communication and collaboration among standards and other functional groups utilizing standards. This includes but not limited to training on new standards, impact analysis of changes in standards, including the impact on submissions.
  • With a strong background in at least one of the disciplines of data management, statistical reporting and analysis, the job holder will be conversant in the latest technologies supporting Clinical Development Standards. Additionally, the job holder will be an expert in Pharmaceutical Industry Standards such as the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) as well as associated case report tabulations data definitions (Define-XML) for submission to regulatory authorities.
  • The job holder will be accountable for the scientific correctness of all standards supporting data management, programming, statistical analysis and regulatory submissions.
  • The job holder will have proven leadership experience in broad scale deployment of end-to-end standards and demonstration of business value in terms of increased compliance and reduction in cycle time and cost. In support of driving business value related to investment in Clinical Development Standards, the job holder will ensure the relevant metrics covering development, maintenance; adoption and associated value (time, cost, quality & customer) are in place.
  •  To ensure his/her team are delivering business value on an ongoing basis, the job holder will be responsible to create a continuous improvement framework with respect to Clinical Development Standards and the implementation thereof supported by greater partnerships with internal business partners, suppliers, CRO partners and industry user groups. 
  • Additionally, the job holder will initiate and lead business process changes within the context of data standardization and in collaboration with other partner functions as required.
  • The job holder will lead the Governance to enforce Janssen’s Global Clinical Development Standards strategy, ensuring adherence, balanced vis-à-vis the needs of clinical development to deliver the highest business value. 
  • The job holder will be a member of the IDAR leadership team contributing to the overall IDAR strategy and the successful execution of annual goals and objectives of the IDAR team in line with GCDO and RDO imperatives. The job holder will provide regular updates and insights to the IDAR leadership team on the status of Clinical Development Standards, highlighting operational or scientific roadblocks and proposing potential solutions that will assist in removing the roadblocks.
  • The job holder will be responsible for establishing an internal and external benchmarking network facilitating the distillation of best practices from leading organizations externally whilst also identifying best practices from internal teams within J&J.
  • This position reports to Head IDAR. The job holder will be expected to provide leadership to the Clinical Development Standards team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
  • This position is responsible for a team of more than 30 Janssen Employees globally, in addition to necessary contract and flex support based on portfolio and project demands

 


Qualifications
  • University/college degree is required.
  • An advanced degree (e.g. Masters, MBA, MD, PhD) is preferred.
  • 12 years of experience in the Pharmaceutical Clinical Development industry is required.
  • 5+ years of experience in a senior managerial position leading people is required.
  • Advanced expertise in CDISC, ADaM and SDTM standards is required.
  • Advanced expertise in at least one of the disciplines of data management, statistical reporting and analysis is required.
  • A thorough understanding of clinical research processes is required, with demonstrated expertise in deploying Clinical Development Standards supported by technology is required.
  • Ability to thrive in a global multicultural matrix environment is required
  • Ability to manage high workload and critical issues in a timely manner is required
  • Knowledge of HL7 standards is preferred.
  • This position requires up to 25% travel both domestic and international.
 

Johnson & Johnson is an equal opportunity employer

 


Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
0000187K

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