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Job Title: Senior Clinical Biomarker Research Scientist
Job Category: Other  [ View All Other Jobs ]
Job Reference: 76585777
Job description:
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.
Job Summary

Eisai is searching for a talented, resourceful, self-motivated and proactive Clinical Biomarker specialist to lead the implementation and execution of the project-related clinical biomarker strategy across an innovative neuroscience pipeline. This position will provide technical expertise for identification and selection of high quality clinical biomarker vendors in conjunction with cross-functional study team members. Coordinate with contracting and budgeting teams to ensure vendor responsibilities are clearly defined. Manage oversight of clinical biomarker deliverables in adherence with data integrity, data specifications and regulatory requirements. Collaborate with clinical team members for development and finalization of key clinical study documents including protocols, case report forms, informed consent documents, and instructional manuals for clinical sites. Communicate with study investigators and clinical sites to ensure adherence to specific sample collection and processing for specialized clinical biomarker needs. The candidate is expected to be an active contributor to the cross-functional teams, providing technical expertise where appropriate and acting independently, within a matrixed clinical development organization.  Additionally, the candidate should demonstrate strong verbal and written communication skills and be able to manage tight-timelines.

Essential Functions
* Responsible for executing clinical biomarker plan in alignment with the project team's goals (for example, laboratory manuals, informed consents, analytical plans, and SOWs).
* Coordinate with Clinical Operations team members to assure collection and shipment of biomarker clinical samples from the clinical sites/central laboratory to analysis laboratories.
* Coordinate with internal and external stake-holders (CROs/clinical sites) to address clinical specimen-related issues in a timely manner.
* Develop data transfer specifications by gathering input from translational science leads, data management, and data scientists to ensure delivery of high quality clinical biomarker data transfer.
* Implement clinical biomarker analysis in appropriate clinically validated assay/methodologies.
* Continuously evaluate newer, innovative technology platforms and applicability to clinical biomarker testing.

Requirements
* MS/PhD in Biological Sciences with a minimum of 5 plus years' experience, leading clinical biomarker logistics and operations.
* Prior experience in providing CRO oversight with regards to clinical biomarker testing and experience in pivotal clinical studies including in diagnostic development is not necessary but desirable.
* Outstanding organizational skills and capacity to prioritize multiple tasks
* Excellent people skills with the ability to efficiently interface with multiple groups including clinical operations, data sciences and external CROs.
* Experience in neuroscience and translational science is not required but strongly preferred.
* Embrace and model EISAI core values.
* Travel: Less than 20%

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.  Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work
E-Verify Participation 

JOB REQUIREMENTS:


To apply for this position, please copy and paste the following link into your browser address bar:
https://eisai.contacthr.com/76585777
Skills:
Language requirements: English
Employment type:
  • Full Time
Salary Range: Unspecified
 
Other Information
 
Degree: Doctorate
Experience (year): 5
Job Location: Woodcliff Lake - New Jersey - USA   View a map of this job
Address: Woodcliff Lake
Zip/Postal Code: 07675
Post Date: 08/31/2020
 
Contact/Apply Instructions: To apply for this position, please copy and paste the following link into your browser address bar:
https://eisai.contacthr.com/76585777
 
 
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