Executive Director, Global Clinical Development- Nephrology and Immunology

Otsuka 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 for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.

Culture

As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning “creativity”, gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.

Another Japanese tenet, Jissho-Shugi, means “earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.

Pipeline

Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product’s full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.

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Job Description

Otsuka is currently hiring for an Executive Director, Global Clinical Development – Nephrology & Immunology. The Global Clinical Development function has responsibility for helping to define the Global R&D strategy and direct responsibility for taking all compounds from proof of concept through to Regulatory Approval. This individual will have a specific focus on the Nephrology & Immunology therapeutic areas and manage all aspects on the clinical strategy.

The Executive Director of Global Clinical Development, Immunology/Nephrology will lead a team of five physicians and help to devise/guide the clinical strategy for the organization shaping the framework for clinical results which lead to product registration. As Otsuka continues to expand its focus in this therapeutic area it will continue an aggressive M&A and BD&L agenda. Therefore, this person will be asked to participate in the due diligence of potential acquisitions, in-licensing or joint-development programs for clinical viability and the potential for commercial success.

KEY RESPONSIBILITIES

In addition, the Executive Director will utilize his/her experience, gravitas and leadership to continuously provide ongoing education to Otsuka’s clinical efforts. The specific duties assigned to this role include, but are not limited to:

• Oversee and guide the development of clinical research programs over multiple trials in the US and/or Europe, as well as globally, if necessary.
• Design the clinical trial protocols for the leading compounds in clinical development with a patient-centric focus.
• Manage the relationship with relevant CROs to ensure study design and protocols, patient recruitment, and that trials are executed on time and within budget.
• Review the clinical operating plans and developing the clinical project team utilization plan.
• Monitor ongoing clinical safety of the products.
• Review Scientific manuscripts for publications.
• Oversee the budgets for the projects under development.
• Manage a team of clinical development physicians, with a particular focus on leadership and facilitating team solutions.
• Ensure compliance with FDA and any other relevant Regulatory Authorities.
• Evaluate the clinical data at decision/stage gate points.
• Serve as a true business partner to the organization by incorporating global corporate needs into development decisions, including activity for BD+L/M&A.

YEAR ONE CRITICAL SUCCESS FACTORS

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