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.

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.

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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.

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting EEAccommodations@otsuka-us.com .

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