Executive Medical Director, Clinical Science, GI2 TAU

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Executive Medical Director in our GI2 Therapeutic Area Unit in our Cambridge, MA office.

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​At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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​Here, you will be a vital contributor to our inspiring, bold mission

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​POSITION OBJECTIVES:

​The Executive Medical Director

• leads and drives strategy for the overall global clinical development of an assigned Takeda development franchise or a disease area, taking into consideration the medical, scientific, regulatory, financial and commercial contexts worldwide;
• leads multi-disciplinary, multi-regional, matrix team(s) through highly complex decisions.  This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute on a franchise/disease area strategy and, as applicable, one or more clinical development plans that will result in the regulatory approval of the compound(s) in single or multiple indications worldwide;
• applies clinical/medical decision making to clinical development issues.  This individual interacts with and influences R&D senior leadership decision-making by setting strategic direction for a broad part of Takeda’s neuroscience pipeline.  Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products.

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​ACCOUNTABILITIES: 

​Clinical team leadership and Project Team / Clinical team membership

• Leads clinical teams as Global Clinical Lead or represents Clinical Science on Project and Clinical teams
• Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy.
• ​Contributes to the overall Asset Strategy by leading generation of the Clinical Development Plan, Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions. Recommends scope, complexity and size, and influences the budget of all aspects of a study or program.
• Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Recommends high impact global decisions.
• Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.

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​Synopsis / Protocol Development, Study Execution, & Study Interpretation

• Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor or supervisor to other medical dir