Senior Director, Translational Research and Biomarkers

1h1 hour ago

Otsuka Pharmaceutical Companies

Princeton, US · Full-time · $230,720 – $345,000

About this role

The Senior Director, Translational Research and Biomarkers is an experienced scientific leader who oversees translation of scientific and discovery strategies into innovative Phase 1 and Proof of Concept clinical trials for Otsuka’s portfolio. This role manages development and clinical integration of biomarkers for both early and late-stage assets.

Day-to-day, the Senior Director drives hypothesis-led preclinical efficacy and mechanistic studies, biomarker development, and associated data analytics to integrate diverse data domain analyses and interpretations. The role oversees a team of scientists and collaborates in a matrix environment with global Otsuka Discovery Affiliates and external clinical researchers to align priorities and execute key deliverables under accelerated timelines.

The Senior Director liaises with the Early Development Organization as well as late-stage development groups and other Otsuka research organizations. This leader also collaborates with academic centers, key opinion leaders, and private or publicly funded organizations to ensure robust and impactful translational biomarker plans.

This position offers the opportunity to shape early-phase portfolio strategy and drive differentiation against competitors through rigorous mechanistic biomarker plans and data generation. The Senior Director will recommend and defend clinical trial design elements to senior leadership, including indication selection, population selection, and biomarker assessments.

Requirements

Experienced scientific leader with a strong background in translational research and biomarker development
Ability to drive hypothesis-led preclinical efficacy and mechanistic studies
Experience managing a team of scientists in a matrix environment
Proven ability to collaborate with global discovery affiliates and external clinical researchers
Expertise in biomarker strategy development and integration into clinical trials
Strong data analytics skills to integrate diverse data domain analyses and interpretations
Experience with multi-omics data analysis for mechanism of action and patient stratification
Ability to communicate complex data insights clearly across preclinical, early, and late-stage assets

Responsibilities

Drive the translational and exploratory research strategy within Otsuka’s early phase portfolio by identifying and advancing opportunities to interrogate assets through strategically structured experiments
Manage end-to-end biomarker development for pipeline assets for early and late-stage assets
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, ensuring operational feasibility and fit-for-purpose strategies for FIH/PoC studies
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
Oversee 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
Integrate published evidence with internal preclinical and clinical data to support mechanism of action and differentiation

Benefits

Opportunity to shape early-phase portfolio strategy at a leading pharmaceutical company
Collaboration with academic centers, key opinion leaders, and public/private organizations
Leadership role with direct oversight of a team of scientists
Influence on clinical trial design and biomarker strategy for innovative assets