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

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

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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 E&C program for PDT R&D on a regular basis.
• Contributes to implementation of global E&C program projects, as relevant (Code of Conduct, Values initiatives, Policies and Procedures).
• From time to time, leads global project teams on behalf of Global Ethics & Compliance, with direct impact on the Takeda company‑wide E&C Program. Frequently takes the lead on 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.

Minimum Requirements / Qualifications

Preferred

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Compensation And Benefits Summary

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. U.S. Base Salary Range : $208,200.00 – $327,140.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short‑term and / or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Location

Boston, MA

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