Senior Clinical Research Scientist - Oncology

Eisai Inc
Woodcliff Lake, New Jersey
Competitive Compensation & Benefits Package
Apr 28, 2019
Jun 30, 2019
Full Time
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Job Description:

The Senior Clinical Research Scientist in the Clinical Pharmacology and Biomarker group is responsible for designing and executing the biomarker strategy for assigned clinical trials, in order to contribute to clinical development (i.e.: dose selection using pharmacodynamic (PD) biomarkers, patient selection using predictive biomarkers, indication selection, etc., based on translational research (TR) data). This includes scientific and clinical justifications and rationales for proposed preclinical and clinical biomarker testing, timelines, and operational aspects of implementing the planned translational research strategies. The Senior Clinical Research Scientist will generate new translational/biomarker proposals, operationalize and manage ongoing studies, and communicate translational/biomarker project data to the leadership of the Clinical Biomarker group.

Essential Functions:

1. Develops and Operationalizes the Clinical Biomarker strategy for projects.
2. Must work closely with Clinical Biomarker laboratories to coordinate biomarker testing, results, and analyses.
3. Responsible for collating and analyzing exploratory biomarker and translational data from clinical studies.
4. Responsible for the Clinical Biomarker sections in clinical protocols, informed consents, investigator brochures, Statistical Analysis Plans, laboratory statements of work, technical documents, Clinical Study Reports, and Publications.
5. Maintains positive relationships with internal and external collaborators.
6. Meets timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)
7. Must be capable of working with global project teams (travel should not exceed 15%).



Job Qualifications:


The Senior Clinical Research Scientist should hold a Ph.D., M.D./Ph.D. in Molecular Biology or related field with at least three years of applicable biomarker, clinical trial and/or research experience or M.S. with extensive clinical trial and/or research experience.
• Have a strong background in tumor biology and immunology/immune-oncology, and three or more years of experience in Oncology Translational/Biomarker Research.
• Experience with large omics-type datasets (e.g. from next generation sequencing).
• Have a strong publication record demonstrating relevant experience in clinical trials, early drug development, drug discovery or biomarkers.
• Have sufficient experience coordinating biomarker research with a global clinical trial management. team and to communicate goals and deliverables to other cross-functional teams.
• Have a ‘getting things done’ mentality and is pro-active, enthusiastic and goal-orientated.
• Have familiarity with data science tools, and data analysis software such as image and flow cytometry assays.
• Have excellent verbal and written communication skills in English.