Job Description

Job Summary

The Senior Director, Translational Research and Biomarkers is an experienced scientific leader who oversees translation of scientific and discovery strategies into innovative Phase 1and PoC clinical trials for Otsuka’s portfolio and manages development and clinical integration of biomarkers for early and late-stage assets. The role oversees a team of scientists and drives hypothesis-led preclinical efficacy and mechanistic studies, biomarker development and associated data analytics to integrate diverse data domain analyses and interpretations, yielding clear communication of insights across preclinical, early and late-stage assets.

The Senior Director, Translational Research and Biomarkers will liaise with the Early Development Organization (EDO) as well as late-stage development groups and other Otsuka research organizations and oversees, design, and execution of translational and biomarker projects and collaborates with academic centers, key opinion leaders and private or publicly funded organizations.

Key Responsibilities

Translational Research and Biomarkers

• In collaboration with EDO, drives the translational and exploratory research strategy within Otsuka’s early phase portfolio, by identifying and advancing opportunities to interrogate assets through strategically structured experiments (e.g. in vitro, ex vivo from selected patients, animal models, etc), thereby ensuring 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.
• Manages end-to-end biomarker development for pipeline assets for early and late-stage assets

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, fit-for-purpose strategies, and readiness for FIH/PoC studies, aligned with early development indication development plans.
• Manages team responsible for the selection and integration of biomarkers into clinical trials
• Endorses mechanistic biomarker plans and data generation for presentations and publications to differentiate the competition and increase brand growth
• Recommends to Sr leadership and defends clinical trial design elements, including indication selection, population selection, and biomarker assessments, as appropriate
• Engage external investigators and collaborators to ensure translational biomarker plans are robust and impactful
• Oversees the analysis of large datasets, such as multi-omics, to elucidate mechanism of action, identify fit-for-purpose pharmacodynamic markers, and enable patient stratification in clinical trials

Data Analysis, Synthesis, and Communication

• In partnership with Data & Analytics, provide biologic/mechanistic insights and direction for analyses and visualization of translational research datasets, synthesizing findings with PK/PD, safety, and early clinical outcomes to generate actionable insights.
• Review, interpret, and contribute to internal reports; generate compelling visuals and narratives that distill complex data into actionable business insights and support program decisions.
• Integrate published evidence with internal preclinical and clinical data to support mechanism of action and differentiation.

Study and Regulatory Support

• Ensure 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.
• On invitation, participate in New Target and Indication exercises with Otsuka Discovery Affiliates, including Visterra, Jnana, Astex, ORC and TRC.

Qualifications

Required

• PhD in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or other relevant 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 guidance, communication and 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 & other high-throughput gene expression technologies, 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 in translating results published in the scientific literature to independently design, execute and interpret complex sets of 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

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