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 **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company 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, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job Tags

Temporary work, Local area, Flexible hours,

Similar Jobs