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/
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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 serve multiple roles within the Oncology Prostate Disease Area Stronghold (DAS). As a Translational Research (TR) leader for specific programs, the Associate Director will develop and implement the translational research strategy for portfolio compounds in both early and late stages of development. He/she will serve on Compound Development Teams (CDT) and support the strategy by providing the rationale and justification of the research goals. He/she will guide CDT Oncology Translational project planning and resource modeling and communicate with Translational Leadership, Project Management, Finance, Discovery, and the relevant CDT Lead (CDTL) and Clinical Team (CT) leaders to implement the plans. The TR leader will also lead multiple Prostate DAS disease related internal and external projects to further scientific understanding of disease segments while supporting long-term DAS goals. As project leader across multiple internal and external collaborations, the Associate Director will lead projects and academic alliances set up to address key translational goals and objectives for the compound development strategy and for the Prostate DAS objectives. She/he will also guide development of new platforms and technologies that have applicability to oncology drug development within the Prostate DAS indications. In addition, he/she will ensure common scientific standards for translational data generated in clinical studies or collaborations. The TR leader will interpret and present results that drive compound development decisions. Results will be communicated to the leaders of the Translational Research (TR) group, senior leadership in Janssen Pharmaceutical Research and Development and other relevant Johnson & Johnson business units. The Associate Director will enable delivery on all goals and objectives set for the Oncology TR group and the Prostate DAS including both pre-clinical and clinical projects. Additional responsibilities include but are not limited to:
- Discovery and validation of predictive, pharmacodynamic, prognostic, safety, and disease biomarkers.
- Leading the development of Companion Diagnostics in the cases where they are needed for clinical programs.
- Establishing and maintaining collaborative relationships with internal functional groups, external academic research groups and CROs to facilitate the implementation of Translational and Biomarker Research strategies.
- Delivering the biomarker and translational research sections in NME related documents, Clinical Protocols, Investigator Brochures, Regulatory documents, Clinical Study Report, and technical reports.
- Coordinating proposed analyses within clinical trials with internal and external partners.
- Reporting of biomarker data to the CDT, Oncology senior management and other relevant groups.
- Quality Compliance and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)
- Accurate Resource planning for proposed projects.
- Ph.D. or an M.D./Ph.D. in Molecular Biology, pharmacology or related field with at least 6 years of applicable experience in biomarker and translational research and business experience is required
- At least 2 years of experience in pharmaceutical or biotechnology settings is required
- Background in tumor biology with experience in prostate, lung, breast and/or hematologic biology is preferred
- Discovery and/or translational Immuno-Oncology experience is required
- The candidate will have a strong publication record demonstrating relevant experience in clinical trials, translational medicine/research, early drug development, drug discovery and/or biomarkers
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research MDRequisition ID
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