Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Scientific Director, Companion Diagnostics Lead to be 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 Senior Scientific Director Leads a team that develops end-to-end diagnostic strategies in collaboration with key stakeholders and ensures that the diagnostic strategy is in alignment with the development strategy and with timelines for registration of the pharmaceutical asset.
- Collaborates 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.
- Interacts early with Discovery and Translational Research to understand the predictive hypotheses to be tested for specific programs. Collaborates with internal research capabilities to develop a predictive assay if not already available.
- Selects contract laboratory for testing predictive assays in early clinical development.
- Oversees assay transfer to contract laboratory and ensures proper assay validation by working with subject matter experts within the department.
- Understands CLIA-laboratory, FDA testing guidelines and assay validation requirements.
- Collaborates with Translational Research and with Clinical Research to design studies to test the clinical utility of the companion diagnostic.
- Selects diagnostic partner to deliver potential companion diagnostic kit in time for pharmaceutical registration.
- Manages relationships with contract laboratories and companion diagnostic partners including ensuring in-stream data quality from partners.
- Works with colleagues in Regulatory Affairs to ensure that all relevant regulatory documents (e.g. IDEs, PMAs, etc.) are delivered and communicates 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.
- Supervises personnel to deliver companion diagnostic programs to enable registration of pharmaceuticals.
- Keeps current with novel technologies that have impact on oncology diagnostic testing.
- Aids in selection of diagnostic assay methodologies.
- Maintain familiarity with relevant regulatory requirements both within the USA and abroad.
- PhD degree with at least 12 years experience in drug development is required
- Experience with IVD development is required
- Assay development experience required
- Five years of experience managing a team is required
- Oncology experience required
- Up to 10% domestic and international travel is required
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function