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 and manages the 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.

• In collaboration with EDO, drives the translational and exploratory research strategy within Otsuka’s early phase portfolio, identifying and advancing opportunities to interrogate assets through strategically structured experiments (e.g., in vitro, ex vivo from selected patients, animal models).
• Collaborates 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 throughout early and late‐stage development.
• Oversees implementation of biomarker strategies across preclinical and clinical settings in partnership with Discovery, Nonclinical, Clinical Development, and Clinical Pharmacology.
• Guides the design and execution of translational experimental designs and analysis plans, ensuring operational feasibility, fit‑for‑purpose strategies, and readiness for first‑in‑human/PoC studies aligned with early development plans.
• Manages the team responsible for selecting and integrating 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 senior leadership and defends clinical trial design elements, including indication and population selection, and biomarker assessments.
• Engages external investigators and collaborators to ensure translational biomarker plans are robust and impactful.
• Oversees 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.
• In partnership with Data & Analytics, provides 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.
• Reviews, interprets, and contributes to internal reports; generates compelling visuals and narratives that distill complex data into actionable business insights and support program decisions.
• Integrates published evidence with internal preclinical and clinical data to support mechanism of action and differentiation.
• Ensures sound translational scientific rationale is clearly communicated and captured in relevant documents and reports, in partnership with Nonclinical/Toxicology to evaluate potential or observed on‑target safety/tolerability signals for new targets.
• Engages with scientific investigators, KOLs, and external partners to enable high‑quality execution and scientific exchange; oversees preparation of abstracts, presentations, and manuscripts for conferences and peer‑reviewed publications.
• Participates in New Target and Indication exercises with Otsuka Discovery Affiliates, including Visterra, Jnana, Astex, ORC, and TRC.

• PhD in Life Sciences with at least 10 years of relevant experience in clinical science, clinical research, or a 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…