Otsuka Pharmaceutical Companies (U.S.)
Senior Director, Translational Research and Biomarkers
Otsuka Pharmaceutical Companies (U.S.), Princeton, New Jersey, us, 08543
Senior Director, Translational Research and Biomarkers
Job Summary
The Senior Director, Translational Research and Biomarkers is an experienced scientific leader who oversees the translation of scientific and discovery strategies into innovative Phase 1 and PoC clinical trials for Otsuka’s portfolio. They manage the development and clinical integration of biomarkers for early and late‑stage assets, lead a team of scientists, drive hypothesis‑led preclinical efficacy and mechanistic studies, and spearhead biomarker development and associated data analytics. This role ensures clear communication of insights across preclinical, early, and late‑stage assets.
The director liaises with the Early Development Organization (EDO) and late‑stage development groups, oversees the design and execution of translational and biomarker projects, and collaborates with academic centers, key opinion leaders, and external organizations.
Key Responsibilities Translational Research and Biomarkers
In collaboration with EDO, drive the translational and exploratory research strategy within the early‑phase portfolio, identifying and advancing opportunities to interrogate assets through strategically structured experiments (e.g., in vitro, ex vivo, animal models). Ensure strong linkage between mechanism of action, disease biology, PK/PD, and translatable clinical endpoints.
Collaborate in a matrix environment with global Otsuka Discovery Affiliates and external clinical researchers to align priorities and execute key deliverables under accelerated timelines.
Manage end‑to‑end biomarker development for pipeline assets at all development stages.
Planning and Execution
Oversee implementation of biomarker strategies across preclinical and clinical settings in partnership with Discovery, Nonclinical, Clinical Development, and Clinical Pharmacology.
Oversee design and execution of translational experimental designs and analysis plans; ensure operational feasibility and readiness for FIH/PoC studies aligned with early‑development indication plans.
Manage the team responsible for the selection and integration of biomarkers into clinical trials.
Endorse mechanistic biomarker plans and data generation for presentations and publications to differentiate the competition and increase brand growth.
Recommend to senior leadership and defend clinical trial design elements, including indication selection, population selection, and biomarker assessments.
Engage external investigators and collaborators to ensure robust translational biomarker plans.
Oversee the analysis of large datasets (e.g., multi‑omics) to elucidate mechanisms of action, identify fit‑for‑purpose pharmacodynamic markers, and enable patient stratification in clinical trials.
Data Analysis, Synthesis, and Communication
Partner with Data & Analytics to provide biologic/mechanistic insights and to guide analyses and visualization of translational research datasets, synthesizing findings with PK/PD, safety, and early clinical outcomes for actionable insights.
Review, interpret, and contribute to internal reports; generate compelling visuals and narratives that distill complex data into actionable business insights to support program decisions.
Integrate published evidence with internal preclinical and clinical data to support mechanisms of action and differentiation.
Study and Regulatory Support
Ensure a sound translational scientific rationale is clearly communicated and captured in relevant documents and reports.
Partner with Nonclinical/Toxicology to evaluate potential or observed on‑target safety/tolerability signals for new targets.
External Engagement and Collaboration
Engage with scientific investigators, KOLs, and external partners to enable high‑quality execution and scientific exchange.
Oversee preparation of abstracts, presentations, and manuscripts for conferences and peer‑reviewed publications.
Participate in new target and indication exercises with Otsuka Discovery Affiliates (e.g., Visterra, Jnana, Astex, ORC, TRC).
Qualifications Required
PhD in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or related scientific field and sufficient post‑graduate experience in translational biologic/mechanism research, hypothesis generation, testing and interpretation.
Fundamental knowledge of CNS and immunology and related experimental and assay technologies sufficient to enable productive communication and collaboration with discovery scientists and biomarker/bioanalytic SMEs.
Proficient in core data analytic concepts, genomics and bioinformatic pipelines to enable productive collaboration with data scientists, bioinformaticians, and statisticians.
Demonstrated ability to synthesize multidisciplinary datasets (e.g., clinical, PK/PD, biomarkers, safety) into clear recommendations.
Excellent interpersonal, oral, and written communication skills; strong organization and attention to detail; ability to manage multiple priorities in a matrix environment.
Managerial and supervisory experience.
Proven experience with designing, conducting and interpreting translational research experiments and communicating results in support of drug development decisions and optimizing clinical trial design.
Strong experience with a broad range of biochemical, molecular and cellular assays including scRNA‑Seq, exome and whole‑genome sequencing, high‑throughput proteomics, and multiplex flow cytometry.
Knowledge/awareness of digital biomarker use in clinical trials.
Ability to manage and collaborate on multiple projects in different stages of development under strict deadlines and fluctuating priorities.
Broad experience translating published results in scientific literature to independently design, execute and interpret complex experiments or procedures.
Preferred
Experience contributing to regulatory submissions and health authority interactions.
Extensive hands‑on experience with data analysis and visualization tools to enable productive communication with data & analytic SMEs.
Ability to guide the questions to be addressed in the generation of descriptive visuals and targeted analyses.
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 $225,490.00 – Maximum $337,180.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the role in the United States. Pay may be adjusted based on experience, skills, and internal comparison.
Application Deadline This posting will be open for a minimum of 5 business days.
Company Benefits Comprehensive medical, dental, vision, prescription drug coverage; 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, and other company‑provided benefits.
Disclaimer This job description is intended to describe the general nature and level of work performed. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend responsibilities to meet business needs.
Equal Employment Opportunity 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 expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
Accommodations for Applicants with Disabilities If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation. Contact Accommodation Request.
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The Senior Director, Translational Research and Biomarkers is an experienced scientific leader who oversees the translation of scientific and discovery strategies into innovative Phase 1 and PoC clinical trials for Otsuka’s portfolio. They manage the development and clinical integration of biomarkers for early and late‑stage assets, lead a team of scientists, drive hypothesis‑led preclinical efficacy and mechanistic studies, and spearhead biomarker development and associated data analytics. This role ensures clear communication of insights across preclinical, early, and late‑stage assets.
The director liaises with the Early Development Organization (EDO) and late‑stage development groups, oversees the design and execution of translational and biomarker projects, and collaborates with academic centers, key opinion leaders, and external organizations.
Key Responsibilities Translational Research and Biomarkers
In collaboration with EDO, drive the translational and exploratory research strategy within the early‑phase portfolio, identifying and advancing opportunities to interrogate assets through strategically structured experiments (e.g., in vitro, ex vivo, animal models). Ensure strong linkage between mechanism of action, disease biology, PK/PD, and translatable clinical endpoints.
Collaborate in a matrix environment with global Otsuka Discovery Affiliates and external clinical researchers to align priorities and execute key deliverables under accelerated timelines.
Manage end‑to‑end biomarker development for pipeline assets at all development stages.
Planning and Execution
Oversee implementation of biomarker strategies across preclinical and clinical settings in partnership with Discovery, Nonclinical, Clinical Development, and Clinical Pharmacology.
Oversee design and execution of translational experimental designs and analysis plans; ensure operational feasibility and readiness for FIH/PoC studies aligned with early‑development indication plans.
Manage the team responsible for the selection and integration of biomarkers into clinical trials.
Endorse mechanistic biomarker plans and data generation for presentations and publications to differentiate the competition and increase brand growth.
Recommend to senior leadership and defend clinical trial design elements, including indication selection, population selection, and biomarker assessments.
Engage external investigators and collaborators to ensure robust translational biomarker plans.
Oversee the analysis of large datasets (e.g., multi‑omics) to elucidate mechanisms of action, identify fit‑for‑purpose pharmacodynamic markers, and enable patient stratification in clinical trials.
Data Analysis, Synthesis, and Communication
Partner with Data & Analytics to provide biologic/mechanistic insights and to guide analyses and visualization of translational research datasets, synthesizing findings with PK/PD, safety, and early clinical outcomes for actionable insights.
Review, interpret, and contribute to internal reports; generate compelling visuals and narratives that distill complex data into actionable business insights to support program decisions.
Integrate published evidence with internal preclinical and clinical data to support mechanisms of action and differentiation.
Study and Regulatory Support
Ensure a sound translational scientific rationale is clearly communicated and captured in relevant documents and reports.
Partner with Nonclinical/Toxicology to evaluate potential or observed on‑target safety/tolerability signals for new targets.
External Engagement and Collaboration
Engage with scientific investigators, KOLs, and external partners to enable high‑quality execution and scientific exchange.
Oversee preparation of abstracts, presentations, and manuscripts for conferences and peer‑reviewed publications.
Participate in new target and indication exercises with Otsuka Discovery Affiliates (e.g., Visterra, Jnana, Astex, ORC, TRC).
Qualifications Required
PhD in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or related scientific field and sufficient post‑graduate experience in translational biologic/mechanism research, hypothesis generation, testing and interpretation.
Fundamental knowledge of CNS and immunology and related experimental and assay technologies sufficient to enable productive communication and collaboration with discovery scientists and biomarker/bioanalytic SMEs.
Proficient in core data analytic concepts, genomics and bioinformatic pipelines to enable productive collaboration with data scientists, bioinformaticians, and statisticians.
Demonstrated ability to synthesize multidisciplinary datasets (e.g., clinical, PK/PD, biomarkers, safety) into clear recommendations.
Excellent interpersonal, oral, and written communication skills; strong organization and attention to detail; ability to manage multiple priorities in a matrix environment.
Managerial and supervisory experience.
Proven experience with designing, conducting and interpreting translational research experiments and communicating results in support of drug development decisions and optimizing clinical trial design.
Strong experience with a broad range of biochemical, molecular and cellular assays including scRNA‑Seq, exome and whole‑genome sequencing, high‑throughput proteomics, and multiplex flow cytometry.
Knowledge/awareness of digital biomarker use in clinical trials.
Ability to manage and collaborate on multiple projects in different stages of development under strict deadlines and fluctuating priorities.
Broad experience translating published results in scientific literature to independently design, execute and interpret complex experiments or procedures.
Preferred
Experience contributing to regulatory submissions and health authority interactions.
Extensive hands‑on experience with data analysis and visualization tools to enable productive communication with data & analytic SMEs.
Ability to guide the questions to be addressed in the generation of descriptive visuals and targeted analyses.
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 $225,490.00 – Maximum $337,180.00, plus incentive opportunity. The range shown represents a typical pay range or starting pay for individuals hired in the role in the United States. Pay may be adjusted based on experience, skills, and internal comparison.
Application Deadline This posting will be open for a minimum of 5 business days.
Company Benefits Comprehensive medical, dental, vision, prescription drug coverage; 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, and other company‑provided benefits.
Disclaimer This job description is intended to describe the general nature and level of work performed. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend responsibilities to meet business needs.
Equal Employment Opportunity 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 expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
Accommodations for Applicants with Disabilities If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation. Contact Accommodation Request.
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