Associate Director, Translational Research and Biomarkers

Job Summary

We are seeking an experienced and highly motivated Translational Biomarker Scientist to support biomarker-driven drug development programs covering autoimmune and neurologic diseases. As a key member of cross-functional project teams, you will partner with Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams to advance translational strategies, execute biomarker plans, and generate insights that inform critical clinical development decisions. This role provides the opportunity to drive innovative biomarker approaches and contribute to the development of novel therapies from early development through clinical proof of concept.

Key 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 target engagement/pharmacodynamic (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.

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.

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.

Salary

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

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
• Paid leave programs
• Other company provided benefits

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.