Director, Translational Research and Biomarkers

Otsuka is seeking a naturally curious, self-motivated individual to join the Bioanalytical, Genomics, and Biomarker Research team. The role focuses on innovative projects that bring solutions to clinical programs, including -omics analysis for elucidating mechanism of action, identifying and selecting mechanism-based pharmacodynamic markers, improving clinical trial design through patient enrichment approaches, and correlating genetic variants with clinical assessments. This position offers the opportunity to pioneer genomics and biomarkers in clinical trials, ultimately impacting patient lives.

About the Role

The Director of Translational Research and Biomarkers oversees a team responsible for outsourcing the measurement of biomarkers in biological fluids and tissues to support clinical drug development. The role also involves overseeing the analysis of complex datasets through computational genomics and bioinformatic pipelines, ensuring compliance with global regulatory guidances for reporting and submissions. The individual will collaborate with the Translational Medicine team and other research/project teams to recommend, design, and outsource biomarker and genomics projects that enhance clinical drug development.

Responsibilities

• Leads and/or participates in internal cross-functional project teams for asset development programs with active fluid biomarker projects.
• Manages a team responsible for the selection and integration of biomarkers into clinical trials.
• Endorses mechanistic biomarker plans and manages data generation for presentations and publications to support brand growth.
• Initiates experimental design discussions based on gaps in clinical trial data and aids in developing biomarker and genomic research plans in collaboration with department leadership, project teams, and external opinion leaders.
• Recommends and defends clinical trial design elements (e.g., indication selection, population selection, biomarker assessments) to senior leadership.
• Engages external investigators and collaborators to ensure robust and impactful translational biomarker plans.
• 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 assessments for new technology tools.
• Outsources services and implements/develops tools required to support biomarker and genomics research.
• Recommends and defends emerging technologies for measuring biological fluids in clinical trials.

Requirements

• PhD or MS in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research, or a related scientific field.
• Managerial and supervisory experience.
• Proven experience designing and conducting biomarker and genomics research experiments, as well as 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 at different stages of development under strict deadlines and fluctuating priorities.
• Experience translating scientific literature into independently designed, executed, and interpreted complex experiments or procedures.
• Excellent verbal and written communication skills, including the ability to present complex results and ideas.

Preferred Qualifications

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

Skills

• Accountability for Results: Focus on key strategic objectives, maintain high performance standards, and lead change.
• Strategic Thinking & Problem Solving: Make decisions considering long-term impact on customers, patients, employees, and the business.
• Patient & Customer Centricity: Maintain an ongoing focus on the needs of customers and key stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect to influence at all levels and achieve results.
• Respectful Collaboration: Seek and value diverse perspectives to enhance partnerships and common goals.
• Empowered Development: Actively engage in professional development as a business imperative.

Pay

The typical pay range for this role in the United States is $186,489.00 to $278,875.00, plus incentive opportunities. Actual pay may vary based on job experience, specific skills, and comparison to internal incumbents in the role.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided basic life, accidental death & dismemberment, short-term, and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Additional company-provided benefits.