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 senior director level. Responsible for managing the E&C program across PDT R&D and Medical Affairs, 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 senior leaders on ethics and compliance, shapes strategy, and fosters a culture of integrity.

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 risk, ethics and compliance.
• Guides the PDT R&D leadership team through risk-based decision-making based on regulatory environment and Takeda values.
• Supports delivery of the E&C program, working with the PDT R&D Operations Team.
• Strategically supports the E&C program across PDT BU.
• Leads discussions with senior leaders to embed values-based decision-making principles aligned with Takeda's Values, Takeda-ism, and PTRB model.
• Acts as PDT E&C R&D contact for Global E&C R&D and shapes harmonization with Global R&D and USBU on common challenges (approval processes, SOPs, FMVs).
• Reviews, assesses, and approves activities involving external stakeholders, clinical study protocols, and Medical Plans.
• Leads updates to the E&C Risk Activity Assessment for PDT R&D, ERA, and CRA processes; follows up on risk mitigation with PDT R&D Leadership Team.
• Oversees mitigation and remedial action from monitoring, audit, and case management.
• Leads E&C investigations for PDT R&D; collaborates 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 with other E&C Leaders for consistency.
• Defines and delivers the E&C learning curriculum for PDT R&D using the RITE model and in alignment with PDT BU Learning Plan.
• Ensures E&C curriculum is embedded in annual learning offerings across PDT R&D; facilitates learning sessions.
• Uses the PDT BU PLM tool to assess the current state of controls and E&C program elements for PDT R&D regularly.
• 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; often leads PDT E&C projects with impact across PDT BU.
• Responsible for horizon scanning of external E&C trends and aligns the PDT R&D program accordingly.
• 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 in ethics and compliance within the pharmaceutical industry, focused on R&D and Medical Affairs
• Solid Healthcare Compliance understanding and experience
• Experience with all elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management)
• Familiarity with laws, regulations, and guidelines affecting the pharmaceutical industry (IFPMA, EFPIA, OIG, PhRMA, etc.)
• Experience managing compliance risks related to R&D and Medical Affairs, including risk identification, controls, and mitigation
• Project and change management experience
• Proficiency with Microsoft tools (Office, Co-Pilot) and collaboration tools
• Strong interpersonal and communication skills; ability to advise senior business leaders
• Leadership skills to drive change and lead cross-functional teams
• Ability to influence with and without authority; translate ideas into impactful materials
• Strong data analysis and insights generation abilities
• Proven track record of delivering results on time while managing multiple projects
• Ability to build relationships with stakeholders and maintain executive presence
• Ability to interpret business and regulatory information and legal advice
• Capacity to manage complexity and ambiguity with pragmatic solutions
• Curiosity, learning agility, and openness to innovative approaches
• Operations, process orientation, data analytics, or technical expertise to design and implement compliance processes and controls

Skills

• Data analysis and insights generation
• Regulatory and compliance program design
• Stakeholder management and executive communication
• Risk assessment and mitigation
• Policy development and implementation
• Learning and curriculum design

Education

• Bachelor's degree required

Additional Requirements

• Travel expectations not specified in the description