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, guiding senior leaders, shaping strategy, and embedding values-based decision-making in line with Takeda’s PTRB model. Leads risk management, investigations, audits, learning programs, and cross-functional collaboration to ensure ethical operations and regulatory alignment.

Responsibilities

• Accountable for the 8+1 Ethics and Compliance program for PDT R&D and PDT Medical Affairs.
• Serve on the PDT-R&D Extended Leadership Team as a senior E&C leader with subject matter expertise on risk, ethics, and compliance.
• Guide PDT R&D leadership through risk-based decision-making based on regulatory environment and Takeda Values.
• Support the delivery of the E&C program, working with the PDT R&D Operations Team.
• Strategically support the E&C program across PDT BU.
• Lead discussions with senior leaders to shape the PDT BU‚Äôs organizational mindset around Takeda Values, Takeda-ism, and PTRB.
• Serve as PDT E&C R&D point of contact for Global E&C R&D and harmonization efforts with Global R&D and USBU.
• Review, assess, and approve activities involving external stakeholders, clinical study protocols, and Medical Plans.
• Lead updates to the E&C Risk Activity Assessment for PDT R&D, ERA, and CRA processes; follow up on risk mitigation.
• Oversee mitigation and remedial action from monitoring, audit, and case management.
• Lead E&C investigations for PDT R&D; coordinate with Global Investigations, HR, and Legal as needed.
• Act as point of contact for internal/external stakeholders on E&C PDT R&D priorities.
• Design and establish E&C policies and procedures across PDT R&D; align with other E&C leaders for consistency.
• Define and deliver the E&C learning curriculum for PDT R&D using the RITE model; align with PDT BU Learning Plan.
• Embed E&C Learning Curriculum in annual PDT R&D offerings; facilitate learning sessions.
• Use PLM tool to assess current state of controls and E&C program elements for PDT R&D.
• Contribute to global E&C program projects (Code of Conduct, Values initiatives, Policies/Procedures).
• Occasionally lead global project teams for Global Ethics & Compliance; lead PDT E&C projects with cross-BU impact.
• Horizon scan evolving external E&C trends (US PhRMA, UK OIG, US DOJ/SEC, data privacy) and align with PDT R&D program.
• Support Takeda Digital Ethics and Data Privacy Programs at PDT R&D with collaboration with Head of Digital Ethics & Compliance, PDT BU.

Qualifications

• Minimum Bachelor's degree
• Minimum 8 years of experience in ethics and compliance within the pharmaceutical industry focusing on R&D and Medical Affairs
• Solid Healthcare Compliance knowledge
• Experience with all elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management)
• Experience with laws/regulations/guidance affecting pharma (IFPMA, EFPIA, OIG, PhRMA; anti-bribery; SOPs)
• Experience managing compliance risks related to R&D and Medical Affairs (risk ID, controls, mitigation)
• Project and change management skills
• Experience with Microsoft tools (Office, Co-Pilot) and collaboration platforms
• Strong interpersonal/communication skills; ability to challenge and advise business
• Strong leadership and change management abilities; lead cross-functional teams
• Ability to translate ideas into resonant conversations/materials
• Data analysis and insights generation capability
• Proven track record delivering results on time; multi-project management
• Ability to build relationships with stakeholders; executive presence
• Ability to interpret business/regulatory information and legal advice
• Ability to navigate complexity and ambiguity with pragmatic solutions
• Curiosity, learning agility, and interest in innovative approaches
• Operations/process orientation; data analytics or technical expertise to design and implement compliance processes

Skills

• Data analysis and insights generation
• Strategic thinking and leadership in ethics & compliance
• Risk assessment and mitigation planning
• Policy design and implementation
• Learning and development program design
• Internal investigations and collaboration with Legal/HR

Education

• Bachelor's degree required

Additional Requirements

• Travel: Not specified as essential
• Hybrid work policy compliance