Janssen R&D US is recruiting for a Sr. Specialist, 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.
The Sr. Specialist, Oncology Companion Diagnostics Operations will be accountable for coordinating operational aspects of companion diagnostic implementation in clinical trials for assigned program(s)
- Coordinates operational aspects of companion diagnostic implementation in clinical trials for assigned program
- Oversees 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 diagnostic operations input into clinical documents such as protocols and lab manuals
- Able to effectively resolve issues as they relate to samples and assay performance.
- Maintain an overview of status and issues and proactively communicate progress, challenges or changes that may impact timelines
- Effectively and collaboratively works on global cross-functional teams
- Bachelor’s degree in a scientific discipline
- 6-8 years of work experience is required
- Hands-on experience with compliance/oversight of diagnostics assays and samples is required
- Knowledge and understanding of clinical research, ICH GCP, GLP is required
- Oncology experience, preferred
- Ability to develop and maintain strong relationships with internal and external stakeholders
- 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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