Associate Director, Translational Medicine

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 an Associate Director, Translational Medicine, you will support activities related to design, execution 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 execution of early phase trials and biomarker plans. You will work with cross functional teams to identify fit for purpose translational tools in early phase programs to confirm mechanism, biology and proof of efficacy of discovery and early phase compounds. You will work with the Head of Translational Medicine and participate or serve as a co-chair of Research and Development Teams (RDT) to ensure execution and reporting of early phase and Translational Medicine studies. At study level, you will serve as the medical oversight of the study and oversee protocol development, study execution and interact with medical monitor and other functions as well as activities related to Clinical Study Report (CSR). The Associate Director, Translational Medicine, in alignment with 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 endpoint in early phase programs.

You will report to the Executive Director, Translational Medicine.  This position can be based in Princeton, New Jersey, or Rockville, Maryland.  Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs.

Job Description:

• Represent Translational Medicine in cross-functional and internal/external collaborations on activities related to early phase, translational medicine and biomarkers.
• Work with other disciplines within EPTM to incorporate translational and biomarker endpoints in the development plans.
• Serve as team member or co-chair of RDT to ensure proper execution and reporting of early phase and Translational Medicine studies.
• Prepare study design, study outline, participate in defense of early phase protocols 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 stake holders.
• Participate in activities related to study report as a medical representative and ensure proper reporting of study results and communications within Translational Medicine and governance meetings.
• Interact with internal and external groups to evaluate new compounds, molecular and biological targets and new formulation technologies.
• Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds.
• Provide technical and scientific support related to Translational Medicine to internal and external stakeholders and interact with subject matter experts for early development and go/no go decisions related to the discovery as well as early phase assets.

Minimum Qualifications:

• MD with 0-3 years of experience and post doc or Fellowship in Translational Medicine or related areas.
• Training in Translational Medicine, Pharmacology, Clinical development etc..
• Great working knowledge of drug development, clinical development, biomarker and translational tools.
• Current awareness of the latest developments in clinical pharmacology, and guidance documents. 
• 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 and communication skills.
• Flexibility to react rapidly to changing situations/environment.

Preferred Knowledge, Skills, and Abilities:

• Experience in drug development, clinical research, and PK/PD modeling.

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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