Head of Ethics & Compliance Plasma Derived Therapies R&D and Medical Affairs

Role Summary

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, embedding effective risk management into key business processes and conversations, and driving continuous improvement aligned with the strategic evolution of the business.

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. This role collaborates across global E&C teams and PDT stakeholders to ensure the function remains agile, innovative, and aligned with Takeda's vision.

Responsibilities

• 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 helps 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 collaborates on harmonization efforts with E&C Global R&D and E&C USBU.
• Reviews, assesses, and approves activities involving interactions with external stakeholders, clinical study protocols, and Medical Plans.
• Leads 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; follows up on risk mitigation 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; coordinates with Global Investigations Team, HR, and Legal as needed.
• Acts as point of contact for internal and external stakeholders on E&C PDT R&D priorities.
• Designs and establishes relevant E&C policies and procedures across PDT R&D; aligns policies with other E&C leaders to drive consistency and effectiveness.
• Defines and delivers the E&C learning curriculum for PDT R&D using the RITE learning model, aligned with the PDT BU Learning Plan; embeds curriculum across the PDT R&D organization; facilitates learning sessions.
• Uses the PDT BU PLM tool to assess current state of controls and relevant elements of the E&C program for PDT R&D.
• Contributes to global E&C program projects (Code of Conduct, Values initiatives, Policies and Procedures).
• Leads global project teams on behalf of Global Ethics & Compliance; leads PDT E&C projects with impact across PDT BU.
• Horizon scans evolving external E&C trends (US PhRMA, UK OIG, US DOJ, US SEC, US data privacy) and aligns with PDT R&D program.
• Supports Takeda Digital Ethics and Data Privacy Programs at PDT R&D in collaboration with the Head of Digital Ethics & Compliance, PDT BU.

Qualifications

• Minimum Bachelor's degree
• Minimum 8 years of experience in ethics and compliance in the pharmaceutical industry with a focus on Research & Development and Medical Affairs
• Solid understanding and experience of Healthcare Compliance
• Strong familiarity with and experience of all elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management)
• Experience with laws, regulations and industry guidance affecting the pharmaceutical industry (IFPMA, EFPIA, OIG, PhRMA; healthcare SOPs; anti-bribery laws)
• Experience in managing compliance risks related to R&D and Medical Affairs activities including risk identification, controls, and mitigation
• Project and change management skills
• Experience using Microsoft tools (Office, Co-Pilot) and collaboration platforms
• Strong interpersonal and communication skills, with ability to challenge and provide guidance to the business
• Leadership skills to drive change, lead project teams, and influence with and without authority
• Ability to translate ideas into resonant conversations and materials; data analysis and insight generation
• Proven track record of delivering results on time while managing multiple projects
• Ability to build relationships with stakeholders and demonstrate executive presence across management levels
• Ability to identify, analyze, and interpret business and regulatory information and legal advice
• Ability to manage complexity and ambiguity with pragmatic solutions
• Curiosity, learning agility, and interest in innovative approaches
• Operations, process orientation, data analytics, or technical expertise to design and implement compliance processes, controls, and workflows

Preferred

• Strong data analysis and insights generation for decision-making
• Experience using Co-Pilot within Microsoft Office tools
• Experience with AI and collaborative tools to integrate AI into daily operations
• Storytelling with data to communicate complex insights effectively