Otsuka Pharmaceutical Companies (U.S.) · 7 hours ago
Senior Director, Translational Research and Biomarkers
Princeton, NJ
Full-time
Onsite
Director/Executive
$225K/yr - $337K/yr
10+ years expOtsuka Pharmaceutical Companies (U.S.) is seeking a Senior Director, Translational Research and Biomarkers to lead the translation of scientific strategies into innovative clinical trials. This role involves overseeing biomarker development and managing a team of scientists to drive preclinical and clinical research efforts.
Health CareMedical
Responsibilities
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
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
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
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
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
Qualification
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
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided 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
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
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