Director, Translational Research and Biomarkers

Job Summary

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

The Director, Translational Research and Biomarkers oversees a team that outsources measurement of biomarkers in biological fluids and tissues to support clinical drug development. In addition, the Director will oversee the analysis of 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 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.

Job Description

• Leads and/or participates in internal cross functional project teams for asset development programs with active fluid biomarker projects
• Manages team responsible for the selection and integration of biomarkers into clinical trials
• Endorses mechanistic biomarker plans and subsequently manages the data generation for presentations and publications to increase brand growth
• 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
• Recommends to Sr leadership and defends clinical trial design elements, including indication selection, population selection, and biomarker assessments, as appropriate
• Engage external investigators and collaborators to ensure translational biomarker plans are robust and impactful
• Oversees the analysis of large datasets, such as multi-omics, to elucidate mechanism of action, identify fit-for-purpose pharmacodynamic markers, and enable patient stratification in clinical trials
• Contributes expertise to support business development due diligence projects
• Participates in feasibility for new technology tools
• 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

• PhD or MS in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or other relevant scientific field
• Managerial and supervisory experience
• 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
• 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

Preferred

• Knowledge of digital biomarker use in clinical trials
• Proficient in computational genomics and bioinformatic pipelines, including biological interpretation of results
• Vendor management experience, specifically overseeing timelines, deliverables, conformity with contractual agreements, and regulatory compliance
• Experience contributing to regulatory submissions and health authority interactions