Director, Takeda Safety Board Office

3316 Takeda Development Center Americas • Cambridge, MA

5d • Hybrid

About The Position

Partners with the 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, 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 a key member of the DQS Strategy & Operations team, leading assigned projects to drive organizational goals and operational excellence.

Requirements

• Bachelor’s Degree Science or business-related field
• 8 years direct experience in the pharmaceutical industry or related field required
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry
• Demonstrated ability to work across functions, regions, and cultures
• Demonstrated leadership with the ability to inspire, motivate and drive results
• Demonstrated strong project management capabilities
• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
• Demonstrates leadership presence and confidence across all levels of the organization, including Executive level leaders

Nice To Haves

• Advanced degree in science or business is desired
• Previous experience influencing senior-level management and key stakeholders is a plus

Responsibilities

• 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.

Benefits

• Compensation is an important factor as you consider the next step in your career.
• We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
• For information about our benefits, please click here.

What This Job Offers

• Job Type: Full-time
• Career Level: Director