Associate Director, Translational Medicine - Princeton, United States - Otsuka

Otsuka

Verified Company

Princeton, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 crossfunctional 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 cochair 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.

Minimum Qualifications:

MD with 03 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.
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.

MS1

LI-Remote

Li-Hybrid

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.

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