Medical Director, Neuroimmunology

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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 a Medical Director, Neuroimmunology in our Cambridge, MA office.

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.

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

POSITION OBJECTIVES:

The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases.  Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with serious, complex diseases. 

The Medical Director – Hematology, Neuroimmunology & Specialty Care (HNSC) leads and drives strategy for the overall global (US/EU/Japan/ other regions and countries) clinical development for Neuroimmunology, specifically focusing on development of products targeting indications in neuromuscular diseases such as CIDP among others. The candidate will apply their expertise in Neurology to clinical development, taking into consideration the medical, scientific, regulatory and commercial perspectives. They will lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility and accountability for development decisions assessing and integrating the input from various disciplines to create and maintain a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development processes. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.

POSITION ACCOUNTABILITIES:

• Clinical Development team participation and leadership

  • Leads neuroimmunology clinical development for a given product and/or indication and may represent Clinical Medicine on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.

  • Establishes and drives development team strategy and deliverables producing the clinical development strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides 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.

  • Responsible for high impact global decisions with respect to neurology/neuroimmunology: 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. Plans clinical development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and/or commercial viability of a product.

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

  • Drives neuroimmunology clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies.  Serves as an advisor to assoc. med directors and cl