Associate Director, Bioanalysis, Genomics & Biomarker Research
Otsuka Pharmaceutical

Job Info

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Job Summary

Otsuka is looking for a naturally curious, self-motivated individual to join the Bioanalytical, Genomics, and Biomarker Research team. In addition to regulated bioanalysis, innovative analytical measurement projects that focus on clinical trial outcomes and process improvement, such as biomarker discovery, selection and qualification and genetic variant correlation with clinical endpoints are just a part of what we invest our energy in. If you are looking for an opportunity to pioneer in the field of genomics and biomarkers in clinical trials, look no further. *This position can be located in either Princeton, NJ or Rockville, MD.

The Associate Director, Bioanalysis, Genomics & Biomarker Research manages outsourced measurement in biological fluids to support clinical drug development and analyzes complex datasets through computational genomics and bioinformatic pipelines. Compliance with global guidance for reporting and submission to regulatory agencies, when applicable, is maintained. The Associate Director, Bioanalysis, Genomics & Biomarker Research works with the Early Phase and Translational Medicine team as well as other research and project teams to recommend, design, and outsource biomarker and genomics projects to improve clinical drug development. The Associate Director, Bioanalysis, Genomics & Biomarker Research works in collaboration with both internal and external teams, academic centers and private or publicly-funded organizations to implement and/or develop tools to support biomarker and genomic research.

Job Description

• Participates in internal cross functional project teams for Otsuka compounds with active biomarker programs, as applicable
• Initiates experimental design discussions based on existing gaps in clinical trial data and aids in development of biomarker and genomic research plans in collaboration with Bioanalysis, Genomics, and Biomarker Research department head, project teams, and external opinion leaders
• Outsources services and implements and/or develops tools required to support biomarker and genomics research
• Recommends and defends emerging technology to support measurement in biological fluids in clinical trials
• Supports data-driven projects, such as biospecimen management and reconciliation

Qualifications/ Required

Knowledge/ Experience and Skills:

• PhD with at least 7 years of relevant experience, or B.S. or M.S. degree with at least 10 years of relevant experience
• Proficient in computational genomics and bioinformatic pipelines
• Proven experience with designing and conducting biomarker and genomics research experiments and reviewing and interpreting data to support drug development and improve clinical trial design
• Strong experience with a broad range of biochemical, molecular and cellular assays, including but not limited to: mass spectrometry, ELISA, next generation sequencing (NGS), gene expression at the RNA and protein levels, and FACS
• Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance
• Excellent verbal and written communication skills
• Ability to manage and collaborate on multiple projects in different stages of development under strict deadlines and fluctuating priorities
• Efficiency in communicating and presenting complex results and ideas
• Experience in translating results published in the scientific literature to independently design, execute and interpret complex sets of experiments or procedures

Travel (approximately 20%)

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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