Johnson & Johnson Careers
Principal Research Scientist-Oncology Translational Research Leader
Spring House, Pennsylvania
Requisition ID: 2776190426
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Scientist, 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 Principal Scientist-Oncology Translational Research Leader will be the lead for compound specific program(s) in Solid Tumor Targeted Therapy disease area supporting pre-clinical and clinical studies. You will be project lead for solid tumor disease characterization efforts focused on targeted therapies, immuno-oncology and other key areas. You will be the point of contact for clinical and diagnostic teams, collaborators, translational and discovery teams on biomarker strategy and execution
In this position, you will serve multiple roles within the Oncology Solid Tumor Targeted Therapy Disease Area Stronghold (DAS). As a Translational Research (TR) leader for specific programs, you will:
– Develop and implement the translational research strategy for portfolio compounds in both early and late stages of development.
– Serve on Compound Development Teams (CDT) and support the strategy by providing the rationale and justification of the research goals.
– In conjunction with Companion Diagnostics Lead develop the strategy, execution and oversight for compound specific Companion Diagnostics, where applicable.
– 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.
– Lead multiple Solid Tumor Targeted Therapy DAS internal and external projects including academic collaborations to address key translational goals and objectives for compound development strategy, or further scientific understanding of disease segments, while supporting long-term DAS goals.
– Guide development of new platforms and technologies that have applicability to oncology drug development within Solid Tumor Targeted Therapy DAS indications.
– Ensure common scientific standards for translational data generated in clinical studies or collaborations.
– Interpret and present results driving 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.
– Enable delivery on goals and objectives set for the Oncology TR group and the Solid Tumor Targeted Therapy DAS including both pre-clinical and clinical projects.
You will manage translational and biomarker strategies by:
– Planning and executing for discovery and validation of predictive, pharmacodynamic, prognostic, safety, and disease biomarkers.
– Planning and managing a Translational Research budget and resources to support biomarker discovery and validation studies as well as analysis of clinical samples.
– Establishing and maintaining collaborative relationships with internal functional groups, external academic research groups and CROs to facilitate the implementation of Translational Research strategies in clinical trials.
– Leading collaborations and projects with external key opinion leaders in the field.
– Coordinating clinical trial biomarker analyses with internal and external partners.
– Analysis of biomarker data from clinical trials and preclinical studies, interpretation and application of results to clinical development strategy
– Reporting biomarker data to the CDT and Oncology senior management.
– Delivering the biomarker sections in Clinical Protocols, Investigator Brochures, Compound Development Plans, generation of Clinical Study Report, and Regulatory documents including but not limited to IND and NDA/ BLA supporting reports.
– Gaining internal alignment on translational research strategy, and championship of the strategy to internal and external stakeholders and regulatory agencies.
– Compliance with and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)
– A Ph.D. or an M.D./Ph.D. in Molecular Biology or related field with at least five (5) or more years of applicable biomarker, translational research, program management, clinical trial and/or research experience of which two or more years of pharmaceutical or biotechnology industry research experience is required.
– Strong communication skills required.
– Strong background in tumor biology, immune-oncology, project management, and laboratory management experience preferred.
– Experience with companion diagnostic or assay development preferred
– Strong publication record demonstrating relevant experience in clinical trials, translational medicine/research, early drug development, drug discovery and/or biomarkers preferred.
– Strong experience in drug discovery and/or early development to represent a diverse translational research group on a compound development team (CDT) preferred
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC. (6084)