Principal Scientist - Oncology Translational Research Leader (1 of 2)


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 responsibilities include but are not limited to:

Key responsibilities:
• Oncology Translational Research Lead for compound specific program(s) in Prostate disease area supporting pre-clinical and clinical studies.
• Project lead for Prostate Disease Characterization efforts focused on Immuno-Oncology or other key areas

Summary of Responsibilities

The Translational Research Lead will serve multiple roles within the Oncology Prostate Disease Area Stronghold (DAS). As a Translational Research (TR) leader for specific programs, he/she 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.
- 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 Prostate DAS disease related internal and external projects including academic alliances setup up to address key translational goals and objectives for the 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 the Prostate DAS indications.
- Ensure common scientific standards for translational data generated in clinical studies or collaborations.
- 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.
- Enable delivery on all goals and objectives set for the Oncology TR group and the Prostate DAS including both pre-clinical and clinical projects.
Essential functions include management of translational and biomarker strategies by:
• Planning and execution of 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
• 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, other IND and NDA/ BLA supporting reports.
• Gaining strategy alignment internally, and defend the strategy to internal and external stake holders, and regulatory agencies.
• Coordinating proposed analyses within clinical trials with internal and external partners.
• Compliance and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)

Qualifications
Qualifications:

• The Principal Scientist will hold 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.
• Strong background in tumor biology, immune-oncology, project management, and laboratory management experience preferred.
• Strong publication record demonstrating relevant experience in clinical trials, translational medicine/research, early drug development, drug discovery and/or biomarkers preferred.
• Strong communication skills required.
• Strong experience in drug discovery and/or early development to represent a diverse translational research group on a compound development team (CDT) preferred

Primary Location
United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
2277180524
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