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Director, Oncology Companion Diagnostic Operations

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Job Description


Janssen R&D US is recruiting for a Director, Oncology Companion Diagnostics Operations for the Oncology Companion Diagnostics team.  At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.   Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.   

 
Position Description

The Director, Oncology Companion Diagnostics will be accountable for overseeing and coordinating the operational aspects of companion diagnostic implementation in clinical trials for assigned program(s)

 
Key Responsibilities
  • Oversees and coordinates all operational aspects of companion diagnostic implementation in clinical trials for assigned program(s)
  • Line manager of a diagnostics operations team
  • Provide direction to and oversight of assay work performed at external CROs
  • Ensures real time monitoring and oversight of samples from accessioning to final report
  • Ensures resolution of queries arising from sample QC at test site and clinical site, resolves queries at test lab
  • Provide expert diagnostic operations input into clinical documents such as protocols and lab manuals
  • Establishes internal working group to leverage expertise and site engagement locally
  • Able to effectively resolve issues as they relate to samples and assay performance.  Proactively identify trends and develop/implement solutions to mitigate
  • Maintain an overview of status and issues and proactively communicate progress, challenges or changes that may impact timelines
  • Recruits, manages and provide leadership, strategic direction for new staff
  • Develops new processes and procedures, as required
  • Effectively and collaboratively works on global cross-functional teams


Qualifications
  • Master’s degree in a scientific discipline, preferred
  • 8-10 years of work experience
  • Extensive hands-on experience with compliance/oversight of diagnostics assays and samples
  • Strong knowledge and understanding of clinical research, ICH GCP, GLP
  • Oncology experience, preferred
  • Line management experience
  • Experience working on global, matrixed teams
  • Ability to develop and maintain strong relationships with internal and external stakeholders
  • Experience managing vendors and external partners
  • Excellent written and verbal communication skills
 

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.

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Primary Location
United States-Pennsylvania-Spring House-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
4862200110