Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
As a Director of Translational Medicine, you will be a champion of Otsuka's culture and values, and will be responsible for design, execution, oversight and reporting of First in Human (FIH), Translational Medicine (TM) and Proof of Concept (POC) studies and will work with Discovery, Preclinical, Biomarker, Genomics, Bioanalytical and Global Clinical Development teams to ensure efficient and scientific execution of early phase trials and development/execution of biomarker plans and identification and utilization of new biomarker and translational tools, new technologies and scientific capabilities to support Otsuka's pipeline.
The Director TM works with digital and diagnostics groups to support development of biomarkers throughout the life cycle of Otsuka's compounds. You will represent TM at teams to identify, introduce, and evaluate discovery assets and ensure incorporation of translational tools in early phase programs. You 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 provide medical oversight of ongoing studies and input to strategy and commercial teams for asset and indication mapping. At the study level, the Director of TM will serve as the medical oversight of the study and oversee protocol development, study execution while working with the medical monitor and other functions and activities related to Clinical Study Report (CSR).
The Director of TM, in alignment with the Head of the Translational Medicine, will participate in Key Opinion Leader (KOL) meetings, advisory boards, academic and scientific groups to ensure evaluation and incorporation of innovative translational and biomarker endpoints in early phase programs.
This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. Remote options will be considered for US candidates.
Job Description:
- Serve as chair of RDT to ensure execution and reporting of FIH, Experimental Medicine, Translational Medicine or POC studies.
- Prepare study design, study outline, participate in defense of FIH, Experimental Medicine, Translational Medicine or POC studies in review meetings, review and finalize study protocols.
- Serve in the role of medical oversight of early phase studies and oversee protocol development, study execution, interaction with medical monitor and other cross-functional stakeholders.
- Support identification and utilization of latest Biomarker, Translational tools, new technologies and scientific capabilities to support 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 and 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 and 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 and collaboration with Biomarker, Genomics and Bioanalytical, Digital, and other functions for early go/no go decisions, patient stratification and dose selection.
- 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.
- Develop and implement scientifically driven yet practical clinical biomarker and translational plans to address important program-level questions with cross-functional team.
- Serve as EDT member or RDT chair for multiple early Phase and discovery programs.
- Author or review clinical study protocols, investigator brochures, study reports, INDs, NDAs and CTAs.
- Demonstrate a 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.
Minimum Qualifications:
- MD or MD/PhD in Pharmacology, Neuropsychopharmacology (or a related area) with a minimum of 5-10 years of experience.
- In-depth experience in design, execution and reporting of first in Human, Translational studies and biomarker research.
- Medical oversight of FIH, Experimental Medicine, Translational Medicine or POC studies.
- In-depth knowledge of Translational Medicine, Pharmacology, Neuropsychopharmacology Translational and Pharmacology models.
- Great working knowledge of drug development, clinical development, biomarker, and translational tools.
- In-depth knowledge of the latest developments in clinical pharmacology, and guidance documents.
Preferred Knowledge, Skills, and Abilities:
- Must be able to apply scientific knowledge (in the areas specified above) to further our products, anticipate and identify core problems, apply analysis, and solve problems effectively.
- Strong leadership experience related to Early Phase and Translational Medicine.
- Strong communication skills.
- Flexibility to react rapidly to changing situations/environment.
Our Benefits:
- Comprehensive medical, dental, vision and prescription drug coverage.
- Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance.
- Tuition reimbursement.
- 401(k) match.
- PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
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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.