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Senior Scientific Director, Head of Oncology Diagnostics Laboratories
Spring House, Pennsylvania
Clinical Research MD
Requisition ID: 6303171206
Janssen Research & Development, LLC, a member of Johnson & Johnson Family of Companies, is currently recruiting for a Senior Scientific Director, Head of Oncology Diagnostics Laboratories located in Springhouse, PA with a minimum of 10% travel.
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 Senior Scientific Director, Head of Oncology Diagnostics Laboratories manages the Oncology Diagnostics Laboratories to deliver companion diagnostic assays to support registration of pharmaceutical products. Oversees molecular pathology laboratory to support all histology needs of the entire Oncology therapeutic area.
• Collaborates with Discovery, Translational Research and Clinical Research to determine and clarify companion diagnostic laboratories contributions to companion diagnostic projects. Ensures that the laboratories develop histologic and molecular genomic assays that are needed to test predictive hypotheses in support of specific programs.
• Ensures that Clinical Teams, Compound Development Teams, and other stakeholders are kept up to date surrounding progress of the assay development program.
• Understands CLIA-laboratory, FDA testing guidelines and assay validation requirements. Ensures validation of assays developed in the laboratories to the extent needed for the intended use. Approves validation reports and technical reports.
• Ensures that laboratory contributions to regulatory documents are delivered accurately and on time. Communicates with regulatory authorities when required.
• Manages molecular pathology laboratory resources to meet the needs of Discovery and Translational Research. This includes support of in vivo model investigations and also pharmacodynamic biomarker assay development.
• Recommends contract laboratories to support clinical development. Ensures proper assay transfer to, and validation at, contract laboratories by serving as, or overseeing, a subject matter expert within the department.
• Perform technical audits of contract laboratories and report findings in the form of written reports.
• Evaluates and recommends diagnostic partner to deliver potential companion diagnostic kit in time for pharmaceutical registration. Works with companion diagnostic lead to manage collaborations with diagnostic partners.
• Ensure that all laboratory data is generated in compliance with appropriate regulations, policies and SOPs and that laboratory results are reported in the form of written and oral reports.
• Responsible that the general condition of the oncology diagnostics laboratories is well maintained in accordance with applicable policies and procedures.
• Keeps current with novel technologies that have impact on oncology diagnostic and biomarker testing.
• Maintain familiarity with relevant regulatory requirements both within the USA and abroad.
• A minimum of a M.D. degree is required, Ph.D. is preferred.
• A minimum of 15 years’ experience in laboratory management is required.
• A minimum of 10 years of Pharmaceutical industry experience is required.
• Experience with diagnostic development is required.
• Oncology drug development experience required
• Assay development experience required.
• Board certification in Anatomic Pathology is required.
• Board certification in Hematopathology is preferred.
• Board certification in Molecular Genetic Pathology is preferred.
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Clinical Research MD