Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, 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 oncology, immunology, neuroscience, 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate 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. Additional responsibilities include but are not limited to the following:
- 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 organizations 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
- M.D., D.V.M., V.M.D. or equivalent with at least 3 years post graduate training in academia or industry is required
- Oncology experience is required
- Experience with immunohistochemistry assay validation is required
- Board certification in Anatomic Pathology and/or Molecular Genetic Pathology is preferred
- Familiarity with digital pathology imaging is preferred
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research MDRequisition ID