Associate Director – Translational Research and Biomarkers

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

🌎 Translator / Interpreter

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Serve as a core translational biomarker representative on cross-functional asset teams supporting clinical development programs • Develop and execute biomarker strategies, including target engagement/pharmacodynamic biomarkers, patient stratification approaches, and mechanism-of-action hypotheses • Support indication and patient population selection by integrating translational and clinical biomarker data • Identify, select, and oversee biomarker assays in biological matrices • Manage outsourced activities and external laboratory partners • Develop biomarker analysis plans and support generation, review, and interpretation of clinical biomarker data for interim and final study analyses • Collaborate with internal and external stakeholders to deliver biomarker activities on time and to 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 • Present biomarker strategies, data, and recommendations to project teams and governance committees • Partner with Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams to advance translational strategies and inform clinical development decisions

🎯 Requirements

• 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 • 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

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity