Senior Director, Translational Medicine (MD) - Nephrology/Immunology

The Senior Director Translational Medicine will be responsible for design, execution and reporting of First in Human (FIH), Translational Medicine (TM) and Proof of Concept (POC) studies and will work closely with Discovery, Preclinical, Biomarker, Genomics, Bioanalytical and Global Clinical Development teams to ensure efficient and scientific execution of early phase trials as well as development and execution of biomarker plans as well as identification and utilization of emerging biomarker and translational tools, new technologies and scientific capabilities in support of Otsuka's pipeline. The Senior Director TM works closely with Head of TM as well digital and diagnostics groups to support development of biomarkers throughout life cycle of Otsuka's compounds. The Senior Director TM will represent TM at cross functional teams to identify, introduce, and evaluate discovery assets and ensures incorporation of translational tools in early phase programs. Senior Director TM will participate in the Early Development Team (EDT) or serve as chair of Research and Development team (RDT) and support transition of discovery compounds from preclinical stage to first in human and POC and provides input to strategy and commercial teams for asset and indication mapping. The Senior Director TM will represent the TM group in governance and development teams and will support activities related to direct reports in TM group.

Job Description

• Oversee identification and utilization of emerging Biomarker, Translational tools, new technologies and scientific capabilities in support of Otsuka's pipeline.
• Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds and Translational tools.
• Provide expert advice to internal and external stakeholders and interact with subject matter experts for early development and go/no go decisions.
• Provide expert advice to internal and external discovery teams as well as academic and early investment partners on incorporation of Translational tools and studies in early development, lead optimization and go/no go decisions.
• Collaborate with internal and external discovery teams as well as BD, MSRD on activities related to early phase target and asset identification.
• Support development of biomarker plans for each compound in alignment with functional head as well as collaboration with Biomarker, Genomics and Bioanalytical, Digital, and other functions for early go/no go decisions, patient stratification and dose selection.
• Propose, design, and execute FIH, Experimental Medicine, Translational Medicine or POC studies.
• Work in close collaboration with Strategy and Commercial teams to identify new modalities and targets and execute internal and external Translational studies for target validation and discovery of new compounds.
• Review and approve INDs, NDAs and CTAs.
• Support Head of TM in planning, staffing, budgeting, expense priorities.
• Support talent development within TM team to ensure technical and scientific capabilities are aligned with department's future plans.
• Develop and implement scientifically driven yet practical clinical biomarker and translational plans to address key program-level questions in alignment with cross-functional team.
• Serve as EDT member or RDT chair for multiple early Phase and discovery programs.
• Represent Translational Medicine on cross-functional teams and make strategic contributions to the clinical development plans.
• Review and approval of clinical study protocols, investigator brochures, study reports, etc.
• Support budget and timeline activities across multiple studies/programs.
• Demonstrate a strong track record in early clinical drug development, including the principles of clinical pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for implementation.

Qualifications/ Required

Knowledge/ Experience and Skills:

Knowledge and Competencies
* In-depth knowledge of Translational Medicine, Pharmacology, Neuropsychopharmacology Translational and Pharmacology models.
* Great working knowledge of drug development, clinical development, biomarker, and translational tools.
* Current awareness of the latest developments in clinical pharmacology, and guidance documents.

Skills
*Must be able to apply scientific knowledge (in the areas specified above) to further the company's products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.

*Strong leadership experience related to Early Phase and Translational Medicine.
*Strong organization skills.
*Strong communication skills.
*Flexibility to react rapidly to changing situations/environment.

Travel 20-40%

Educational Qualifications

MD or PhD in Pharmacology, Neuropsychopharmacology (or a related area) with a minimum 10-15 years of experience. In depth experience in design, execution and reporting of first in Human, Translational studies as well as biomarker research.

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.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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