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Job Description

About the role:

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:

• Minimum Bachelor's degree

• Minimum 8 years of experience in the field of ethics and compliance in the pharmaceutical industry with focus on Research and Development and Medical Affairs

• Solid understanding and experience of Healthcare Compliance

• Strong familiarity with and experience of all the elements of an ethics and compliance program (e.g. policies, risk management, learning, monitoring, case management)

• Experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, IFPMA, EFPIA, OIG and PhRMA guidelines, healthcare standard operating procedures, and anti-bribery laws

• 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

• Demonstrated project and change management skills

• Experience of using Microsoft collaboration tools and other programs (e.g. Microsoft Office, Co-Pilot)

• High interpersonal and communication skills including ability to challenge and provide advice/ guidance to business

• Strong leadership skills, including the ability to lead change efforts through effective communication

• Leading project teams and influencing with and without authority

• Proven skills to transform ideas into conversations and materials that resonate

• Effective data analysis and insights generation

• Consistently demonstrates the ability to deliver results, at pace, and on time

• Able to work and deliver on deadlines while managing multiple projects and priorities effectively

• 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.

• Demonstrated ability to identify, analyses, and interpret business and regulatory information and legal advice

• Managing complexity and ambiguity: ability to develop and apply pragmatic solutions to complex legal, regulatory and industry issues

• Mindset of curiosity, learning agility and interest in innovative ways of doing things.

• Strong operations, process-orientation, data analytics, or technical expertise to effectively design, develop and implement compliance and relevant business processes, controls, and workflows

Preferred

• Effective data analysis and insights generation: The role requires strong capabilities in analyzing data and generating insights to support decision-making processes 1.

• Experience of using co-Pilot within Microsoft Office tools and programs (e.g., Microsoft Office, Co-Pilot)

• Experience with AI and Collaborative Tools: experience in utilizing AI bots, collaboration platforms, and other tools to seamlessly integrate AI into daily operations. This includes leveraging AI for automating routine tasks, enhancing team collaboration, and improving overall productivity.

• Storytelling with Data: The ability to effectively communicate complex data insights through compelling narratives. This skill helps in driving informed decision-making and fostering a data-driven culture within the organization.

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. #LI-Hyrbrid

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$208,200.00 - $327,140.00

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.

Locations

Boston, MAUSA - IL - Chicago

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.