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||Princeton, NJ United States
Executive Director Global Medical Strategy|
The Executive Director Global Medical Strategy is a key contributor and member of the Global Medical Affairs Leadership Team (GMLT). Oversees the Global Medical Director teams and Regional European Medical Director team for each therapeutic area. Works cross-functionally with Global and European counterparts in Marketing, Market Access, Value Evidence, Clinical Development and others to create and execute global Strategic Asset Plans for each global and European products. Coordinates the strategic generation of scientific data and the consistent and accurate scientific communication about Otsuka's products globally. Maximizes the partnership between global and regional European medical teams through the combined team reporting structure.
Oversees global medical affairs planning and activities in cross-functional collaboration with other global and regional functions.
Responsible for annual data gap analysis to develop and evolve the product data generation plan for each global asset through its lifecycle.
Responsible for the global evidence generation review process to harmonize the global Phase IIIB and IV programs, including Investigator Sponsored Studies and non-interventional studies
Ensures that clinical trials include outcomes of interest to patients and fulfilling the medical needs in the therapeutic area.
In collaboration with the Head of Global Medical Operations and Communications she/he will help create and execute the Global Publication Plans for each global and regional asset.
Acts as a driving force in the public dissemination of product related data. Ensures that regional offices (OPEL and OIAA) and local affiliates are properly cognizant of all product related data and organizes coordination of medical activities across all regions.
Oversees development of manuscripts, presentations, international symposia, and posters.
Interacts with experts in the field to obtain feedback on clinical aspects of global products and new data generation, interpretation and dissemination
Provides input into regulatory documents, including product labeling
Participates in the evaluation of potential in-licensing candidates
Establishes SOPs and sets standards to ensure that the medical function operates effectively and efficiently and that all medical communications are accurate and of high quality.
Ensures compliance with all relevant Corporate Policies (CO) and Standard Operating Procedures (SOPs).
MD, PhD or PharmD with exceptional leadership experience in the Medical Affairs area
Minimum of 10 years of experience in Medical Affairs with at least 5 years of global responsibilities
At least 5 years of demonstrated supervisory experience with the ability to lead and motivate others globally
Requires extensive understanding of the company's products, clinical development, commercialization strategy, the competition, and the pharmaceutical industry in general.
Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.
Skilled in managing and influencing people in varying cultural settings
Excellent communication and interpersonal skills
Ability to travel up to 30% of time
Experience in Neuroscience or Nephrology
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer: 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.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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