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

Role Summary

The Head of Ethics & Compliance (E&C) for PDT R&D and Medical Affairs is a senior leadership role responsible for managing the E&C program across PDT R&D and Medical Affairs, driving continuous improvement aligned with the business strategy. The role models ethical behavior and embeds effective risk management into key processes, guiding senior leaders on ethics and compliance matters and shaping strategy to foster a culture of integrity. Based in Boston, MA, the role collaborates with global E&C teams and PDT stakeholders to ensure agile, innovative, and values-based decision-making aligned with Takeda's PTRB model.

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 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, 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, coordinating with the Global Investigations Team, HR on disciplinary actions, and Legal on matters of legal interpretation/legal privilege.
• Acts as the point of contact for internal and external 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, aligning them 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 and aligned with the overall PDT BU Learning Plan.
• Ensures that the E&C Learning Curriculum is embedded in the annual learning offerings across the PDT R&D organization and 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 E&C program for PDT R&D on a regular basis.
• Contributes to global E&C program projects, as relevant (Code of Conduct, Values initiatives, Policies and Procedures).
• Leads global project teams on behalf of Global Ethics & Compliance, with direct impact on the Takeda company-wide E&C Program. Frequently leads PDT E&C projects, thereby indirectly leading the PDT E&C team on major programmatic enhancements with impact across PDT BU.
• Responsible for horizon scanning related with evolving external E&C trends (US PhRMA, UK OIG, US DOJ, US SEC, US data privacy regulations) and subsequent alignment with the E&C program for PDT R&D.
• Supports the Takeda Digital Ethics and Data Privacy Programs at PDT R&D working in close collaboration with the Head of Digital Ethics & Compliance, PDT BU.

Qualifications

• Required: Minimum 8 years of experience in ethics and compliance in the pharmaceutical industry with a focus on Research and Development and Medical Affairs.
• Required: Solid understanding and experience of Healthcare Compliance.
• Required: Strong familiarity with and experience of all the elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management).
• Required: Experience with laws, regulations and industry guidance affecting the pharmaceutical industry including, but not limited to, IFPMA, EFPIA, OIG and PhRMA guidelines, healthcare standard operating procedures, and anti-bribery laws.
• Required: Experience in managing potential, present and future compliance risks related to R&D and Medical Affairs activities including risk identification, controls & risk mitigation of potential non-compliance.
• Required: Demonstrated project and change management skills.
• Required: Experience of using Microsoft collaboration tools and other programs (e.g. Microsoft Office, Co-Pilot).
• Required: High interpersonal and communication skills including ability to challenge and provide advice/ guidance to business.
• Required: Strong leadership skills, including the ability to lead change efforts through effective communication.
• Required: Leading project teams and influencing with and without authority.
• Required: Proven skills to transform ideas into conversations and materials that resonate.
• Required: Effective data analysis and insights generation.
• Required: Consistently demonstrates the ability to deliver results, at pace, and on time.
• Required: Able to work and deliver on deadlines while managing multiple projects and priorities effectively.
• Required: Ability to build strong relationships with key stakeholders and ability to demonstrate executive presence while interacting with all levels of management, individual collaborators and partners.
• Required: Demonstrated ability to identify, analyze, and interpret business and regulatory information and legal advice.
• Required: Managing complexity and ambiguity with the ability to develop and apply pragmatic solutions to complex legal, regulatory and industry issues.
• Required: Mindset of curiosity, learning agility and interest in innovative ways of doing things.
• Required: Strong operations, process-orientation, data analytics, or technical expertise to effectively design, develop and implement compliance and relevant business processes, controls, and workflows.
• Preferred: Preferred: Effective data analysis and insights generation. Strong capabilities in analyzing data and generating insights to support decision-making.
• Preferred: Preferred: Experience using Co-Pilot within Microsoft Office tools and programs (e.g., Microsoft Office, Co-Pilot).
• Preferred: Preferred: Experience with AI and collaborative tools, using AI bots, collaboration platforms, and other tools to integrate AI into daily operations and improve productivity.
• Preferred: Preferred: Storytelling with data; ability to communicate complex data insights through compelling narratives to drive informed decision-making and foster a data-driven culture.

Education

• Minimum Bachelor's degree