Associate Director, Translational Research and Biomarkers

Otsuka Pharmaceutical Co., Ltd. • Princeton, MA

3d • $169,222 - $253,000 • Hybrid

About The Position

Otsuka is seeking a curious and self-motivated individual for its Translational Research and Biomarkers team. This role focuses on innovative projects aimed at advancing drug candidates from preclinical research through clinical development. Key areas include -omics analysis for mechanism of action elucidation, identification of pharmacodynamic markers, patient enrichment strategies for clinical trial design, and correlation of genetic variants with clinical assessments. The Associate Director will be an integral part of the Translational Biomarkers team, contributing to drug development by leveraging expertise in immunology, nephrology, clinical translational research, and data analysis. The position involves overseeing outsourced biomarker measurements, managing external partnerships with CROs, laboratories, and academic collaborators, and integrating various data types to inform drug development decisions. Exploratory clinical data analyses using statistical and data visualization approaches, as well as ensuring compliance with global regulatory guidelines, are also key responsibilities. The role supports the design and implementation of innovative biomarker and genomic strategies.

Requirements

• 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 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.

Responsibilities

• 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.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• Company provided 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
• Paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior