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

Role Summary

Head of Ethics & Compliance (E&C) for Plasma Derived Therapies R&D and Medical Affairs. Senior leader 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. 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 values.
• Supports the delivery of the E&C program, working with the PDT R&D Operations Team.
• Strategically supports the E&C program across the PDT BU.
• Leads discussions with senior leaders to embed values-based decision-making principles aligned with Takeda Values and PTRB model.
• Acts as PDT E&C R&D point of contact for Global E&C R&D and harmonization efforts with Global R&D and USBUs.
• Reviews, assesses, and approves activities involving external stakeholders, clinical study protocols, and Medical Plans.
• Leads updates to E&C Risk Activity Assessments, ERA, and CRA processes across PDT R&D; follows up on risk mitigation with PDT R&D Leadership Team.
• Oversees mitigation and remedial action from monitoring, audits, and case management.
• Leads E&C investigations for PDT R&D; coordinates with Global Investigations, HR, and Legal as needed.
• Designs and establishes E&C policies and procedures across PDT R&D; aligns policies with other E&C Leaders.
• Defines and delivers the E&C learning curriculum for PDT R&D using the RITE learning model; aligns with PDT BU Learning Plan.
• Ensures E&C Curriculum is embedded in annual learning offerings; facilitates sessions across the E&C program for PDT BU.
• Uses the PDT BU PLM tool to assess the current state of controls and E&C program elements for PDT R&D.
• Contributes to global E&C program projects (Code of Conduct, Values initiatives, Policies and Procedures).
• Leads global project teams for Global Ethics & Compliance; leads PDT E&C projects with impact across PDT BU.
• Horizon scans evolving external E&C trends and aligns the PDT R&D program accordingly.
• Supports the Takeda Digital Ethics and Data Privacy Programs at PDT R&D in collaboration with the Head of Digital Ethics & Compliance.

Qualifications

• Minimum Bachelor's degree
• Minimum 8 years of experience in ethics and compliance in the pharmaceutical industry with focus on R&D and Medical Affairs
• Solid understanding and experience of Healthcare Compliance
• Experience with all elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management)
• Experience with laws and guidelines affecting the pharmaceutical industry (IFPMA, EFPIA, OIG, PhRMA; healthcare SOPs; anti-bribery laws)
• Experience managing compliance risks related to R&D and Medical Affairs including risk identification and mitigation
• Project and change management skills
• Proficiency with Microsoft collaboration tools and Microsoft Office; familiarity with Co-Pilot
• Strong interpersonal and communication skills; ability to challenge and advise business teams
• Strong leadership and change management capabilities; ability to lead projects and influence without authority
• Ability to translate ideas into impactful communications and materials
• Data analysis and insights generation skills
• Proven ability to deliver results on time, manage multiple projects, and meet deadlines
• Ability to build relationships with stakeholders and demonstrate executive presence
• Ability to interpret business and regulatory information and provide legal insights
• Ability to navigate complexity and ambiguity with pragmatic solutions
• Curiosity, learning agility, and openness to innovative approaches
• Strong operations, process orientation, data analytics, or technical expertise to design and implement compliance processes

Skills

• Data analysis and insights generation
• Experience with AI and collaborative tools to integrate AI into daily operations
• Storytelling with data to communicate complex insights effectively

Education

• Bachelor's degree required

Additional Requirements

• Location: Boston, MA