Associate Director, Translational Research and Biomarkers

Job Summary

Otsuka is seeking a naturally curious, self‑motivated individual to join the Translational Research and Biomarkers team. The Associate Director will advance drug candidates from preclinical research through clinical development, leveraging expertise in immunology, nephrology, and biomarker science. Responsibilities include managing external partners for biomarker measurements, integrating pathway biology data, supporting exploratory analyses, and ensuring regulatory compliance.

• Participate as a key member of cross‑functional project teams supporting asset development programs with active biomarker initiatives.
• Collaborate within a matrixed environment—Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams—to refine translational hypotheses and deliver program‑critical outputs on accelerated timelines.
• Contribute to the design and advancement of scientifically rigorous biomarker and clinical development strategies, including indication and patient population selection, TE/PD biomarker integration, and MoA hypothesis development.
• Oversee the selection, outsourcing, and execution of biomarker assays in biological matrices, and manage external vendors to ensure quality and timeliness.
• Develop and implement biomarker analysis plans and support high‑quality data generation for interim and final clinical analyses.
• Ensure compliance with global regulatory requirements and contribute to the preparation, review, and interpretation of biomarker‑related clinical and regulatory documents.
• Evaluate, recommend, and help defend the adoption of emerging technologies and innovative approaches for biomarker measurement in clinical trials.

• PhD or MS with a minimum of 5 years of relevant experience in clinical research or clinical trial execution within immunology or nephrology.
• Demonstrated experience designing and executing biomarker and genomics research, with a proven ability to analyze, interpret, and translate data to support drug development and inform clinical trial design.
• Strong expertise across a broad range of biochemical, molecular, and cellular assay platforms, as well as bioinformatics approaches, including RNA‑Seq, exome and whole‑genome sequencing, high‑throughput proteomics, and multiplex flow cytometry.
• Working knowledge of digital biomarker applications and their integration into clinical development programs.
• Experience managing external vendors, including oversight of timelines, deliverables, contractual obligations, and regulatory compliance.
• Proven ability to manage and contribute to multiple programs at different stages of development, effectively prioritizing work in a fast‑paced environment with evolving timelines.
• Demonstrated ability to translate insights from scientific literature into the design, execution, and interpretation of complex experiments and research strategies.
• Excellent verbal and written communication skills, with the ability to clearly present complex scientific concepts and data to diverse cross‑functional audiences.

Approximately 10% travel.

• Accountability for Results – Focus on strategic objectives, hold 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 a focus on the needs of customers and key stakeholders.
• Impactful Communication – Communicate with logic, clarity, and respect, influencing at all levels to achieve best results.
• Respectful Collaboration – Seek and value diverse perspectives to enhance work toward common goals.
• Empowered Development – Play an active role in professional development as a business imperative.

Minimum $ – Maximum $ plus incentive opportunities.

Comprehensive medical, dental, vision, prescription drug coverage, basic life, accidental death & dismemberment, short‑term and long‑term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave.

Otsuka is an equal‑opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.