Director, Clinical Trial Reporting

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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 the Director, Clinical Trial Reporting based remotely 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:

• Set the vision, direction, and strategy for area(s) of responsibility and actively contribute to and align with the overall Global Development Office (GDO) strategies and operating models. 

• Responsible for the effective leadership, strategic planning, and oversight for Clinical Trial Reporting (CTR) organization. Ensure on time, high quality, and within budget delivery for all assigned CTR activities globally within a key asset, franchise/portfolio and/or therapeutic area(s).

• Provide CTR expertise and leadership in support of global development programs as well as post-marketing registration and non-registration studies.

• Drive strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.

• Ensure that technologies used in clinical trial(s) (e.g., Jreview, Veeva CDM, R, RShiny) at Takeda are implemented in a compliant manner.  

• Responsible for oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.

• Accomplished people and relationship manager, establishing and maintaining productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers.

• Champion CDOS operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CTR capabilities.

• Responsible for direct line management of employees.

• Partner with Data Configuration Engineer, and Clinical Data Standards teams …