Senior Clinical Research Scientist - Oncology
- Employer
- Eisai Inc
- Location
- Woodcliff Lake, New Jersey
- Salary
- Competitive Compensation & Benefits Package
- Closing date
- Jun 30, 2019
View more
- Position
- Principal Scientist
- Category
- Clinical Research Oncology, Clinical Trials Research, Translational Research
- Hours
- Full Time
- Career Fair Category
- Career Fair
Job Details
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.
Company
Welcome to Eisai Inc.
Eisai Inc. (pronounced ā-zī) is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd, a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business.
Headquartered in Woodcliff Lake, New Jersey, we are dedicated to a tradition of genuine concern for people and are driven by the desire to help meet the diverse health care needs of patients and their families and caregivers. We are an agile, entrepreneurial organization managed by experienced leadership, backed by the strength, stability and historical successes of Eisai Co., Ltd., which has a strong and lasting commitment to the U.S. market.
Our heritage and mission have earned us recognition as an innovative, efficient, solution-oriented pharmaceutical company - a company that effectively works with healthcare professionals, hospitals and managed care organizations to develop and market specialty products that help address unmet needs. Our ability to forge strong alliances gives us a competitive edge.
In the United States, our rapid growth and strong performance result from putting patients and their families first when making decisions and from empowering the people who manage our operations. Eisai employees personify our values of integrity, respect, professionalism, quality and teamwork.
As you continue exploring our corporate web site, you will learn more about how our commitment to hhc is a motivating force for everything we do and everything we produce.
- Website
- http://www.eisai.com/
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