Johnson & Johnson Careers

Associate Scientific Director

Spring House, Pennsylvania
Clinical Research MD


Job Description

Requisition ID: 6266171206

Janssen Research & Development, LLC, a member of Johnson & Johnson Family of Companies, is currently recruiting for an Associate Scientific Director 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 Associate Scientific Director will be the subject matter expert in the Oncology Diagnostics Laboratory responsible for analytical validation of histology assays developed by the molecular pathology laboratory.

ESSENTIAL FUNCTIONS:

• Scientific management of the design, execution and analytical validation plan of immunohistochemistry assays for the evaluation of predictive and pharmacodynamic biomarkers in both human tissues and in vivo pharmacology models.
• 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 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
• A minimum of a M.D. degree is required, Ph.D. is preferred.
• Oncology experience is required.
• Experience with immunohistochemistry assay validation is required.
• Board certification in Anatomic Pathology is required.
• Board certification in Molecular Genetic Pathology is preferred.
• Board certification in hematopathology is preferred.


Primary Location
United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Research MD
Requisition ID
6266171206