Senior Director, Clinical Trial Configuration

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Trial Configuration based in Cambridge, MA reporting to the VP, Clinical Data Operations & Standards.

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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

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

GOALS:

• Responsible for effective leadership, strategic planning, and oversight for an organization that supports the configuration and maintenance of technologies supported by Clinical Data Operations & Standards and are utilized in support for clinical trials. 
• Sets the vision, direction, and strategy for area(s) of responsibility and actively contributes to and aligns with the overall Global Development Office (GDO) strategies and operating models.  Leads operationalization activities to ensure on time, high quality and within budget delivery that enable successful trial data analyses for Takeda to deliver medicines to patients faster. 
• Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
• Ensures that technologies used in clinical trial(s) (e.g., EDCs, eCOA, eConsent, Telehealth, IRT, devices, EDCs and RBQM Data Enablement & Analytics) at Takeda are implemented in a compliant manner.  
• Is an accomplished people and relationship manager, establishing and maintaining productive partnerships within Clinical Data Operations & Standards, functional leaders across R&D, and third party service providers. 
• Lead and organize the Clinical Data Configuration technology systems strategy, in collaboration with preferred vendors, therapeutic area units and IT, to support the timely and efficient delivery of global development programs with high quality and within allocated budget.

ACCOUNTABILITIES:

• Lead a group supporting the clinical trial configuration activities including EDC database builders, RBQM Data Enablement & Analytics, 3rd party data (e.g., IRT, DCT, external data) who configure tools that serve different business needs, including but not limited to: Database build & integration in support of Takeda clinical trials, configure tool for RBQM to perform risk review, develop standardization (e.g., EDC library, DTA/DTS templates, RBQM configurations) and innovative use of latest data tools and technologies.

• Foster and ensure close collaboration with SET members (Clinical, Clinical Data Managers, Statistical Programmers, Statisticians and other stakeholders) in the clinical data lifecycle.

• Drives strategy with preferred vendors to ensure compliance to standards for all development programs and marketed products to ensure regulatory submission compliance.

• Manage team of employees and contractors to assist clinical trial configuration team to maintain compliance.

• Manage Clinical Trial Configuration organization to e