Job Summary

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.

Job Description

• 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.

Qualifications
• 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.

Travel (approximately 10%)

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.