Director, Takeda Safety Board Office

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); Hybrid; USD 166,000 - 278,000; Full time

Job summary

Takeda Cambridge, MA seeks a strategic operations leader to direct the Safety Board (TSB) processes and drive operational excellence. You will partner with senior stakeholders, coordinate global activities, and own key safety and data governance processes across the organization.

The role requires extensive pharmaceutical industry experience, proven leadership, and strong program management capabilities. The position is hybrid, offering collaboration across sites and functions with competitive

Qualifications

• Bachelor’s Degree Science or business-related field
• Advanced degree in science or business is desired
• 8 years direct experience in the pharmaceutical industry or related field required
• Demonstrated leadership with the ability to inspire, motivate and drive results

Responsibilities

• Partners with Global Project Leaders and senior leaders to support decision-making for TSB interactions
• Leads logistics and project management of TSB activities and maintains materials
• Maintains TSB processes, SOPs, playbooks and training materials
• Analyses and reports TSB performance against KPIs and ensures cross-functional alignment

Skills

Leadership

Communication

Project management

Strategic thinking

Cross-functional collaboration

Education

Bachelor’s degree in science or business

Advanced degree desired

Job description

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.

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 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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Bachelor’s Degree Science or business-related field
• Advanced degree in science or business is desired
• 8 years direct experience in the pharmaceutical industry or related field required
• Previous experience influencing senior-level management and key stakeholders is a plus
• 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

TAKEDA COMPENSATION AND BENEFITS SUMMARY

We 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.

Location: Cambridge, MA

Base Salary Range: $177,000.00 - $278,080.00

The 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

EEO STATEMENT

Takeda 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.

WORK LOCATION AND TYPE

Locations Cambridge, MA

Worker Type Employee

Worker Sub-Type Regular Time

Type Full time

Job Exempt Yes

LEGAL NOTICE

It 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.

TAKEDA VALUES

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.