Director, Operational Systems

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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, Operational Systems based remotely reporting to the Senior Director, Trial Delivery Systems Strategy.

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:

• Accountable for functional/business ownership of operational systems used in trial delivery (CTMS, Risk Systems, eTMF, etc.).
• Partners with Data, Digital & Technology partners to drive roadmap prioritization and delivery for successful system operationalization.
• Serves as Business System Owner (BSO) for operational systems used in trial delivery.

ACCOUNTABILITIES:

• Builds and maintains strong functional (GDO) and cross-functional (R&D, Enterprise) stakeholder relationships for an understanding of key challenges and business priorities
• Maintains strong collaboration with R&D DD&T(digital, data, technology) teams for roadmap development and rollout.
• Partners with R&D DD&T leadership in the development and delivery of operational system roadmap.
• Serves as BSO (Business System Owner) for operational systems to support Software Development Lifecycle.
• Responsible for inspection readiness of operational systems and representation of system expertise for inspection-facing activities. 
• Represents operational systems in inspection readiness and GCP inspections.

• Supports change management for operational systems and roadmap evangelism.

• Supports the Sr. Director, Trial Delivery Systems Strategy in leading cross-functional efforts to build out processes and infrastructure necessary to support Takeda ways of working.
• Stays informed on vendor and innovation landscape for operational systems.
• Responsible for annual budget planning, forecasting and budget management for operational systems; oversight of system investment budget for build and run/support activities.
• Defines and tracks value realization for system investments across operational systems.
• Serves as the Subject Matter Expert (SME) and roadmap evangelist for operational systems.

EDUCATION AND EXPERIENCE:

• BS/BA required with 10 years of relevant experience in the life sciences, drug development, trial delivery technology implementation, product management, or strategic roadmap definition
• Direct experience with Veeva Vault Clinical suite (CTMS, eTMF) highly preferred
• Direct experience with software implementation within biopharma organizations highly preferred
• Demonstrated experience in GCP inspection settings, with a deep understanding of system compliance requirements, including GxP validation and 21 CFR part 11 requirements, requirements around blinded data, experience supporting system regulatory inspections.
• Hands-on experience managing the implementation of operational systems for trial delivery (CTMS, eTMF vendor management, inspection-facing listings)
• Demonstrated experience w