Senior Director, Translational Research and Biomarkers

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.

• 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.

• 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.

• 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.

• 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.

• 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).

• PhD in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research or related scientific field and…