Acts as the scientific lead for clinical program development activities within a product group or within a portfolio. Determines product and portfolio level standards for clinical development planning, scientific document content, data analysis and reporting, and reporting to senior management, OPCJ and affiliates. Ensures that scientific content of development plans and protocols meets requirements for simultaneous regulatory submission and optimal market access. Supports Medical Affairs and other functional areas in reporting program activities and results. Serves as a “resident expert” within OPDC for issues related to clinical development planning, program management, and internal reporting. May directly supervise clinical management personnel. Serves as a member of the Clinical Management Leadership Team.
Knowledge: advanced knowledge of clinical trial design, the drug development process, and the clinical concepts involved in assigned projects. Must be a credible and knowledgeable representative of project to KOLs and Investigators. Advanced understanding of drug development principles and clinical trial implementation and management. Strong knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing. Understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business
Skills: Excellent skills in designing and managing global clinical trials and the ability to contribute strategically to development of clinical development programs from first-in-man through life-cycle management. Must be able to form and articulate a clear vision to successfully guide all clinical team members (e.g., internal staff and external investigators/consultants). Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Required: Bachelor’s degree with a minimum of 12 years of applicable pharmaceutical industry experience. Previous supervisory experience.
Preferred: Advanced degree
Travel: up to 25%
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.
In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.