Senior Director, Translational Research and Biomarkers

* 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
* 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
* 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.

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.

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 Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations.

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