Associate Director, Translational Research and Biomarkers

Job Summary

Otsuka is looking for a naturally curious, self-motivated individual to join the Translational Research and Biomarkers 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 pharmacodynamic 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 translational research and biomarkers in clinical trials that will ultimately impact the lives of patients, look no further.

The Associate Director of Translational Research and Biomarkers is an integral member of the Translational Biomarkers team and plays a pivotal role in advancing drug candidates from preclinical research through clinical development. This position requires expertise in immunology and nephology, clinical translational research, and data analysis, visualization and interpretation. Reporting to the Senior Director, Translational Research and Biomarkers, the Associate Director will collaborate closely with cross‑functional partners across Research, Nonclinical, Bioanalytical, Regulatory, Clinical Operations, Quantitative Pharmacology, and Medical teams.

This role is responsible for overseeing outsourced biomarker measurements in biological fluids and tissues to support clinical development programs. The Associate Director will manage external partnerships with contract research organizations, laboratories, and academic collaborators, ensuring high‑quality, timely execution of biomarker strategies. The Associate Director will integrate target engagement, pharmacodynamic, pathway biology, and disease biology data to generate mechanistic insights that inform drug development decisions.

This role also supports exploratory clinical data analyses using robust statistical and data visualization approaches. Additionally, the Associate Director ensures compliance with global regulatory guidelines for biomarker data generation, reporting, and submissions, when applicable. The individual will contribute to the design and implementation of innovative biomarker and genomic strategies, working collaboratively with internal teams and external partners—including academic institutions and research organizations—to advance translational research capabilities.

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

• Participate as a key member of cross‑functional project teams supporting asset development programs with active biomarker initiatives.
• Collaborate effectively within a cross‑functional, matrixed environment—including Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams—to refine translational hypotheses and deliver high‑quality, 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.
• Contribute to 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 to enable biomarker measurement in biological matrices for clinical trials.

• PhD or MS with a minimum of 5 years of relevant experience in clinical research or clinical trial execution within immunology/nephrology.
• Demonstrated experience designing and executing biomarker and genomics research, with a proven ability to analyze, interpret, and translate data to support drug…