Associate Scientific Director (Pathologist), Oncology

Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Scientific Director (Pathologist), in the Oncology Therapeutic Area located in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company. 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 an Associate Scientific Director (Pathologist), you will act as the pathology subject matter expert in Oncology Translational Research responsible for analytical validation of immunohistochemistry assays developed by the Molecular Pathology Laboratory and provide pathology-related consultation services across the Janssen Oncology portfolio. RESPONSIBILITIES INCLUDE: Scientific management of the design, execution and analytical validation plan of immunohistochemistry assays for the evaluation of predictive and pharmacodynamic biomarkers in human tissues. Approve validation reports and technical reports for molecular pathology assays. Contribute to relevant regulatory documents when required. Approve assay transfer quality for assays transferred to external contract research laboratories and companion diagnostic partners in support of clinical development and companion diagnostic development. Perform technical audits of contract laboratories, including companion diagnostic site laboratories, and report findings in the form of written reports. Provide scientific direction and expertise in the area of pathology for both non-clinical and clinical study experiments, including writing relevant sections of clinical trial protocols. Communicate pathology results in the form of written and oral reports and disseminate regular written project updates to line management and relevant compound development team members. Evaluate, interpret and report pathology based clinical study conclusions to Translational Research representatives, to clinical development teams and to physicians participating in clinical trials as appropriate. Maintain familiarity with CAP and CLIA regulations Maintain familiarity with relevant regulatory requirements surrounding companion diagnostic development. Keep current with technological developments that impact molecular pathology. Qualifications • M.D. or D.O. degree is required. • Board certification in Anatomic Pathology is required. • Experience and/or training in digital image analysis is preferred. • Oncology and immunohistochemistry assay validation experience is preferred. • Additional board certification in Clinical Pathology is desired. • Ph.D. degree is desired. 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 ERADICATE CANCER Primary Location United States-Pennsylvania-Spring House-Welsh & McKean Roads Other Locations North America Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206027768W