Janssen Research &
Development, LLC, a member of the Johnson & Johnson Family of Companies, is
recruiting for a Scientific Director-Oncology Companion Diagnostics, in the
Oncology Therapeutic Area located in Spring House, PA.
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 neuroscience, oncology, immunology, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
As a Scientific Director-Oncology Companion Diagnostics, you will develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure that the diagnostic strategy is in alignment with the development strategy and with timelines for registration of the pharmaceutical asset.
• Collaborate with key stakeholders, including, but not limited to, Discovery, Translational Research, Clinical Research, Regulatory and Commercial teams to develop a diagnostic strategy to enable registration of a pharmaceutical asset.
• Interact early with Discovery and Translational Research to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal research capabilities to develop a predictive assay if not already available.
• Select contract laboratory for testing predictive assays in early clinical development.
• Oversee assay transfer to contract laboratory and ensure proper assay validation by working with subject matter experts within the department.
• Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements.
• Collaborate with Translational Research and with Clinical Research to design studies to test the clinical utility of the companion diagnostic.
• Select diagnostic partner to deliver potential companion diagnostic kit in time for pharmaceutical registration.
• Manage relationships with contract laboratories and companion diagnostic partners including ensuring in-stream data quality from partners.
• Work with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (e.g. IDEs, PMAs, etc.) are delivered and communicate with regulatory authorities when required.
• Regularly communicates updates to, and seeks feedback from, Clinical Teams, Compound Development Teams, and other stakeholders where appropriate, surrounding progress of the companion diagnostic program.
• Supervise personnel to deliver companion diagnostic programs to enable registration of pharmaceuticals.
• Keep current with novel technologies that have impact on oncology diagnostic testing.
• Aid in selection of diagnostic assay methodologies.
• Maintain familiarity with relevant regulatory requirements both within the USA and abroad.
• Master’s Degree is required, PhD Degree is strongly preferred
• Experience with In Vitro Diagnostics assay development is required
• 12 years of Drug Development experience is strongly preferred
• Oncology experience is strongly preferred
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)