Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for Principal Scientist/Associate Director, located in Spring House, PA, Boston, MA, La Jolla, CA, South San Francisco, CA or remotely in the U.S. REmote work options may be considered on a case by case basis and if approved by the company.
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 significant unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit www.janssenrnd.com/ for more information.
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The Solid Tumor Targeted (ST3) Translational Research (TR) group is seeking an experienced clinical biomarker lead (Principal Scientist/Associate Director ) to develop and execute key aspects of Janssen's translational efforts directed towards the clinical development of novel therapies across multiple areas of solid tumor focus.
The Principal Scientist/Associate Director will serve multiple roles within the ST3 TR. As a Translational Research leader for specific programs, you will serve on Compound Development Teams (CDT) for the Oncology Translational Research group within the ST3 DAS. In addition, you will lead multiple ST3 disease related internal/external projects to further scientific understanding of ST3 cancer.
You will provide scientific leadership in preclinical and clinical translational research programs within the ST3 TR group. You will develop and implement the clinical biomarker strategy for programs in early and late clinical development. Key goals will include determining proof of mechanism, informing and supporting dose, defining pharmacodynamic markers and biomarkers of response and resistance. You will need to develop strong collaborations with many functional groups across the Oncology Therapeutic Area (TA), including Discovery and Clinical organizations. Additionally, you will need to develop scientific collaborations external to the organization to develop novel insights from clinical samples into disease biology and segmentation.
Key responsibilities include:
- Manages the translational strategy and implementation for one or more pipeline assets.
- Planning and execution of discovery and validation of predictive, prognostic, safety, and disease biomarkers
- Develop, implement and deliver on the clinical biomarker strategy for the compound, participate in the compound development teams and lead pertinent working groups.
- Lead and guide working groups to implement clinical biomarker and translational research strategy and lead ongoing programs and projects.
- Managing a cross-functional translational research team including junior scientists, lab scientists, computational biologists, and other relevant functions as needed.
- Analyze, interpret and present emerging clinical biomarker data
- Regular reporting of biomarker data to the CDT and Oncology senior management.
- Responsibility for the biomarker sections in Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Report
- Managing the outstanding or in-house coordination of proposed analysis within clinical trials.
- Compliance and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)
- Work closely across groups and functions to explore novel indications and new drug combinations for compounds in clinical development.
- Generate pre-clinical experimental plan, oversee/supervise the studies, and integrate into clinical development plan.
- Communicate project deliverables to the leaders across the Oncology Therapeutic Area (TA), and other senior governance groups when necessary.
- Interact and liaise with internal experts, external experts, academic groups, and CROs to establish collaborations and projects.
- Fulfill regulatory responsibilities including preparing, updating, and finalizing regulatory documents.
- You are required to have a Ph.D. or an M.D./Ph.D. in molecular biology or related field with at least 5-10 years of applicable biomarker, translational research, program management, clinical trial and/or research experience, preferably in an industrial setting.
- This person will have a strong background in tumor biology, project management, laboratory management, and five or more years of pharmaceutical or biotechnology industry research experience.
- Extensive experience in designing and execution of pre-clinical research, in-vitro and in-vivo pharmacology, and mechanism of action studies is required
- Experience in clinical biomarker/translational research is strongly preferred
- Familiarity with the techniques common to translational research including, but not limited to, flow cytometry, genomics, proteomics and importantly, data analysis.
- The candidate must have strong communication skills and sufficient leadership experience in drug discovery and/or early development to represent a diverse TR group on a compound development team (CDT) and to communicate goals and deliverables to senior management and governance committees throughout J&J.
- Experience in running multi-faceted projects and programs is preferred.
- Excellent written and verbal communication skills
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States-Massachusetts-Boston, United States-California-San Diego, United States-California-South San Francisco
Janssen Research & Development, LLC (6084)