Director, Takeda Safety Board Office Cambridge, Massachusetts Category: Project/Process Management

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionOBJECTIVE: Partners with Takeda Safety Board (TSB) Chair to develop the strategic direction of the TSB and enable its operational excellenceProvides operational and project management leadership to facilitate TSB processes and activities for TSB including escalation and company-wide communicationEnsures training on TSB processes, and continuous improvement by incorporating learnings into ways of working and performance measurementFunctions 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 communicationTakes the lead on additional assigned projects to drive organizational goals and operational excellenceActs as SME overseeing the Reference Safety Information (RSI) CAPA-related activitiesOversees PSPV business continuity plan, monthly department meetings, and PSPV Satori CouncilServes as key member of DQS Strategy & Operations team, leading assigned projects to drive organizational goals and operational excellence.ACCOUNTABILITIES: 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 activitiesMaintains TSB materials in centralized location, ensuring adequate access to information such as pre-read, meeting minutes, and closeout of all action itemsLeads 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 modelExpedites 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 EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Bachelor’s Degree Science or business-related fieldAdvanced degree in science or business is desired8 years direct experience in the pharmaceutical industry or related field requiredPrevious experience influencing senior-level management and key stakeholders is a plusHealth care business acumen with a comprehensive understanding of the pharmaceutical industryDemonstrated ability to work across functions, regions, and culturesDemonstrated leadership with the ability to inspire, motivate and drive resultsDemonstrated strong project management capabilitiesExcellent communicator, able to persuasively convey both ideas and data, verbally and in writingDemonstrates leadership presence and confidence across all levels of the organization, including Executive level leadersThis position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Takeda Compensation and Benefits SummaryWe understand 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 Location:Cambridge, MAU.S. Base Salary Range:$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. For information about our benefits, please click here.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.