Otsuka is looking for an energetic, motivated, talented individual to join the Bioanalytical team with experimental design experience in either drug development or molecular biology . In addition to regulated bioanalysis, innovative measurement projects, that focus on clinical trial outcomes and process improvement, such as biomarker analysis, microsampling for PK sample collection, 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 the field of biological measurement, look no further. The Bioanalytical team is responsible for managing the outsourced measurement in biological fluids to support clinical drug development , with focus on drug concentrations and their metabolites and pharmacogenomics in support of PK assessments. In addition, responsibilities include research design for exploratory genomics and other -omics technologies, as well as emerging technology for the assessment of mechanism of action and biomarker identification.
The Associate Director, Bioanalytical and Biomarkers will have proficient knowledge in global bioanalytical guidance regulations and understanding of how bioanalytical data flows from the laboratory to regulatory submissions. Strong analytical experience, particularly HPLC-MS/MS and genomics platforms, cell-based technologies, such as flow cytometry, as well as experience with vendor management is strongly preferred.
The individual will be responsible for managing vendors who generate bioanalytical data and ensuring data is auditable, submission-ready and of high quality. He/she will contribute to method development problem solving and support data-driven projects, such as biospecimen management. In addition, he/she will be responsible for surveying the clinical trial measurement landscape and make recommendations on process and technological improvements. The individual should maintain awareness of evolving trends in analytical techniques to support clinical trials and defend innovation projects to the project teams. He/She must have excellent verbal and written communication skills, strong organizational skills, and be able to manage multiple projects in different stages of development under strict deadlines and fluctuating priorities.
Limited travel is required.
PhD with at least 7 years of relevant experience, or B.S. or M.S. degree with at least 10 years of relevant experience
Broad biological pre-clinical research experience (i.e., molecular and cellular assays)
Experimental design and analysis in pharmaceutical research (i.e., bioinformatics, genomics, statistics)
Manage and participate in cross-functional teams and external collaborations
Proven efficiency in communicating complex results and ideas
Established publication record
Proficient in global bioanalytical regulatory guidances
Vendor management experience, specifically overseeing timelines, deliverables, and regulatory compliance
Ability to manage and collaborate on multiple complex projects
Excellent verbal and written communication skills, organizational, inter-personal, communication and demonstrated presentation skills
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