Director, Takeda Safety Board Office

OBJECTIVE

Partners with Takeda Safety Board (TSB) Chair to develop the strategic direction of the TSB and enable its operational excellence. Provides operational and project management leadership to facilitate TSB processes and activities for TSB including escalation and company-wide communication. Ensures training on TSB processes, and continuous improvement by incorporating learnings into ways of working and performance measurement. Functions as Business Process Owner (BPO) for Data Monitoring Committee (DMC), Internal Review Committee (IRC), and First in Human Committee (FiH).

Develops, implements and maintains TSB company-wide communication. Takes the lead on additional assigned projects to drive organizational goals and operational excellence. Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities. Oversees PSPV business continuity plan, monthly department meetings, and PSPV Satori Council. Serves as key member of DQS Strategy & Operations team, leading assigned projects to drive organizational goals and operational excellence.

• Partners with Global Project Leaders, Global Safety leads, PSPV Therapeutic Areas Heads, and other senior leaders to collect and analyse information supporting the decision-making process to trigger a TSB interaction (e.g. ad hoc Meeting, Milestones Review or Forum)
• Collaborates with the Chair-TSB, PRC office and PSPV Therapeutic Area Heads to initiate and triage TSB interactions. Collect necessary information to enable Chair, TSB to triage TSB interactions in alignment with established governances and processes (e.g. Other Important Safety Information, Safety Management Team, GLOC, QAM, PCMC) and follow through on action items implementation and tracking in close collaboration with Global Program Teams.
• Oversees logistics and project management of TSB activities.
• Maintains TSB materials in centralized location, ensuring adequate access to information such as pre-read, meeting minutes, and closeout of all action items.
• Leads maintenance of the TSB processes (e.g. TSB SOP, training slides, and playbook), and ensures that targeted training across all levels at Takeda are conducted to ensure understanding of TSB readiness and operating model.
• Expedites escalation, decision making and communication related to TSB activities.
• Analyses and reports TSB performance based on strategic and business goals, working with TSB Chair to measure against Key Performance Indicators (KPIs).
• Functions as the Business Process owner for Data Monitoring Committee (DMC), Internal Review Committee (IRC) and First in Human Committee (FiH):
  Sets the strategic direction for the process, in coordination with functional experts.
• Leads developing, authoring, maintaining & approving procedural document (SOP), operating model RACI, associated templates / forms, training material, technology capabilities.
• Liaises with other stakeholders (peer function, quality), ensuring cross-function alignment and escalating issues to sponsors.
• Develops global training needs in collaboration with Process, Training and Digital Solutions (PTDS).
• As a member of the Strategy and Operations Team, provides input to key strategic & portfolio activities that may include:
  Project management support for DQS initiatives, change-management activities and organization of department meetings.
• Supports business analytics and key initiatives enabling operational deliverables aligned with organizations goals.
• Supports DQS business continuity plan.
• Foster and maintain an engaging culture and continuously improve DQS and PSPV ways of working.
• Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities.

• Bachelor’s Degree…