Senior Associate Director, Translational Biomarkers

Otsuka Pharmaceutical Co., Ltd

Northern (KY)

Hybrid

USD 169,000 - 253,000

Full time

14 days+

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Job summary

Otsuka Pharmaceutical Co., Ltd. in the United States is seeking an experienced Translational Biomarker Scientist to support biomarker-driven drug development programs across autoimmune and neurologic diseases.

You will partner with Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams to advance translational strategies and generate insights for critical clinical decisions.

Qualifications

PhD or MS in Immunology, Neuroscience, Molecular Biology, Genomics, Pharmacology, or a related scientific discipline.
Minimum of 5 years of relevant experience in translational medicine, biomarker sciences, clinical research, or clinical development within immunology and/or neurology.
Strong knowledge of biomarker discovery, validation, and application in clinical drug development.
Expertise in biochemical, molecular, cellular, and genomic technologies, including RNA-Seq, exome and whole genome sequencing, proteomics, multiplex flow cytometry, and related analytical approaches.
Experience utilizing bioinformatics tools and interpreting complex multi-omics datasets.
Understanding of digital biomarker technologies and their potential application in clinical development.
Knowledge of global clinical research regulations, GCP principles, and biomarker-related regulatory considerations.
Demonstrated ability to manage multiple priorities and operate effectively in a fast-paced, matrixed environment.
Strong scientific problem-solving, critical thinking, and data interpretation skills.
Excellent verbal and written communication skills, with the ability to communicate complex scientific concepts to both technical and non-technical audiences.

Responsibilities

Serve as a core translational biomarker representative on cross-functional asset teams supporting clinical development programs.
Contribute to the development and execution of biomarker strategies, including TE/PD biomarkers, patient stratification approaches, and mechanism-of-action hypotheses.
Support indication and patient population selection through integration of translational and clinical biomarker data.
Identify, select, and oversee biomarker assays in biological matrices, including management of outsourced activities and external laboratory partners.
Develop biomarker analysis plans and support the generation, review, and interpretation of clinical biomarker data for interim and final study analyses.
Collaborate with internal and external stakeholders to ensure biomarker activities are delivered on time and meet scientific, operational, and quality expectations.
Contribute to biomarker-related clinical study documents, regulatory submissions, and responses to health authority requests.
Evaluate and implement emerging technologies, digital biomarkers, and novel assay platforms that enhance biomarker measurement and clinical trial execution.
Present biomarker strategies, data, and recommendations to project teams and governance committees.