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Job Description

About the role:

The Head of Ethics & Compliance (E&C) for PDT R&D and Medical Affairs at the senior director level is a senior leader responsible for managing the E&C program across PDT R&D and Medical Affairs, and driving continuous improvement aligned with the strategic evolution of the business. Role modeling ethical behavior and embedding effective risk management into key business processes and conversations are critical success factors. In alignment with Takeda's values of Takeda-ism and the Patient-Trust-Reputation-Business (PTRB) decision-making model. Embedded in the business and a member of the PDT-R&D Extended and PDT E&C Leadership Teams, this role guides and directs senior leaders on all matters of ethics and compliance, shapes strategy, and fosters a culture of integrity. Key responsibilities include oversight of stakeholder interactions, clinical protocols, and medical plans; leading risk assessments and mitigation plans; overseeing investigations and audits; and delivering E&C training. The role also supports global initiatives, digital ethics, and data privacy efforts, while staying ahead of regulatory trends. Reporting to the Head of E&C for PDT, this leader collaborates across global E&C teams and PDT stakeholders to ensure the function remains agile, innovative, and aligned with Takeda's vision.

How you will contribute:

• Accountable for the 8+1 Ethics and Compliance program for PDT R&D and PDT Medical Affairs.

• Serves on the PDT-R&D Extended Leadership Team as a senior E&C leader with subject matter expertise on matters of risk, ethics and compliance.

• Guides the PDT R&D leadership team through effective, risk-based decision-making, based on the regulatory environment, and the Takeda Values.

• Supports the delivery of the E&C program, working closely with the PDT R&D Operations Team.

• Strategically supports the E&C program across PDT BU.

• Leads discussions with senior leaders and help shape the PDT BU's organizational mindset around Takeda's Values: Takeda-ism and PTRB (Patient-Trust-Reputation-Business)-Model to firmly embed values-based decision-making principles.

• Serves as the PDT E&C R&D point of contact for the Global E&C R&D team and is actively involved in shaping the harmonization efforts with E&C Global R&D, and E&C USBU on common challenges and topics (approval processes, SOPs, FMVs,).

• Reviews, assesses, and approves activities involving interactions with external stakeholders, clinical study protocols, and Medical Plans.

• Leads the continuous updates to the E&C Risk Activity Assessment for PDT R&D, the Enterprise Risk Assessment (ERA) and the Compliance Risk Assessment (CRA) processes across PDT R&D and in close collaboration with other PDT E&C team members, including follow-up of assigned risk mitigation measures with the PDT R&D Leadership Team.

• Oversees mitigation and remedial action from monitoring, audit, and case management.·

• Leads E&C investigations for PDT R&D. As needed, work in close alignment with the Global Investigations Team, with the HR team on disciplinary actions, and with Legal team on matters of legal interpretation/legal privilege.

• Acts as point of contact for internal and external key stakeholders on matters related to the E&C PDT R&D priorities.

• Designs and establishes relevant E&C policies and procedures across PDT R&D. Leads alignment of policies and procedures with other relevant E&C Leaders to drive consistency effectiveness.

• Defines and delivers the E&C learning curriculum for PDT R&D, using the RITE learning model and in alignment with the overall PDT BU Learning Plan.

• Ensures that the E&C Learning Curriculum is appropriately embedded in the annual learning offerings across the PDT R&D organization. Facilitates learning sessions across all aspects of the E&C program for PDT BU.

• Uses the PDT BU Program Lifecycle Management (PLM) tool to assess current state of controls and relevant elements of the