Associate Medical Director, Clinical Science, Neuroscience 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 Associate Medical Director in our Neuroscience 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 Associate Medical Director leads and drives strategy for clinical studies within the overall global clinical development for assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues. Leads or joins multi-disciplinary, multi-regional, matrix team 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 studies within a clinical development plan that will result in the regulatory approval of the compound in multiple regions.  Applies clinical/medical decision making to clinical development issues.  This individual interacts with and influences Neuroscience Therapeutic Area Unit senior leadership decision-making by contributing to strategic direction.  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 participation and leadership

• Represents Clinical Science on Study Execution and Clinical Teams and may serve as co-leader of these teams.

• Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy.

• May act as Global Clinical Lead for an early or a smaller scope product.

• ​Contributes to Global Project and clinical team strategy and deliverables working on the Asset Strategy, Clinical Development Plan, Clinical Protocols and other documents needed for study execution. 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 to other clinical scientists involved in these activities, and be accountabl