Associate Director, Bioanalysis, Genomics & Biomarker Research (Hybrid)

Otsuka is looking for a naturally curious, self-motivated individual to join the Bioanalytical, Genomics, and Biomarker Research team.

Innovative projects that focus on bringing solutions to clinical programs, such as -omics analysis for the elucidation of mechanism of action and identification and selection of mechanism-based pharmacodynamics markers, patient enrichment approaches to improve clinical trial design, and genetic variant correlation with clinical assessments 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 that will ultimately impact the lives of patients, look no further.

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 guidances for reporting and submission to regulatory agencies, when applicable, is maintained. The individual will work 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.

S / He will work 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.

This position can be located in either Princeton, NJ or Rockville, MD.

Responsibilities :

• Participates in internal cross functional project teams for asset development programs with active biomarker projects.
• 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.
• Analyzes large datasets, such as multi-omics, to elucidate mechanism of action, identify fit-for-purpose pharmacodynamic markers, and enable patient stratification in clinical trials.
• 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.

Qualifications / Required :

• PhD or MS in Life Sciences with at least 5 years of relevant experience in clinical science, clinical research or other relevant scientific field.
• Proficient in computational genomics and bioinformatic pipelines, including biological interpretation of results.
• 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 and bioinformatics including RNA-Seq, Exome and Whole Genome Sequencing, high throughput proteomics, and multiplex flow cytometry.
• Knowledge of digital biomarker use in clinical trials.
• Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance.
• Ability to manage and collaborate on multiple projects in different stages of development under strict deadlines and fluctuating priorities.
• Experience in translating results published in the scientific literature to independently design, execute and interpret complex sets of experiments or procedures.
• Excellent verbal and written communication skills, including communicating and presenting complex results and ideas.

Travel (approximately 20%)

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Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.

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Remote working / work at home options are available for this role.