BioSpace
Head of Ethics & Compliance Plasma Derived Therapies R&D and Medical Affairs
BioSpace, Boston, Massachusetts, us, 02298
Head of Ethics & Compliance Plasma Derived Therapies R&D and Medical Affairs
Join to apply for the Head of Ethics & Compliance Plasma Derived Therapies R&D and Medical Affairs role at BioSpace
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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. This role operates in alignment with Takeda values and the PTRB decision-making model. Embedded in the business and a member of the PDT-R&D Extended and PDT E&C Leadership Teams, this leader guides 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 risk, ethics and compliance.
Guides the PDT R&D leadership team through effective, risk-based decision-making based on the regulatory environment and 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 to shape the PDT BU's organizational mindset around Takeda's Values and the PTRB model to embed values-based decision-making.
Acts as the PDT E&C R&D point of contact for the Global E&C R&D team and contributes to harmonization with E&C Global R&D and E&C USBU on common challenges (approval processes, SOPs, FMVs).
Reviews, assesses, and approves activities involving interactions with external stakeholders, clinical study protocols, and Medical Plans.
Leads 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, coordinating with PDT E&C team members and driving follow-up on risk mitigation measures.
Oversees mitigation and remedial action from monitoring, audit, and case management.
Leads E&C investigations for PDT R&D, coordinating with Global Investigations, HR, and Legal teams as needed.
Designs and establishes relevant E&C policies and procedures across PDT R&D and aligns with other E&C leaders for consistency and effectiveness.
Defines and delivers the E&C learning curriculum for PDT R&D, using the RITE model and within the PDT BU Learning Plan.
Ensures the E&C Learning Curriculum is embedded in annual learning offerings and facilitates E&C program sessions across the PDT R&D organization.
Uses the PDT BU Program Lifecycle Management (PLM) tool to assess the current state of controls and relevant elements of the E&C program for PDT R&D.
Contributes to global E&C program projects (Code of Conduct, Values initiatives, Policies and Procedures) and may lead global project teams affecting the Takeda-wide E&C Program.
Leads horizon scanning of evolving external E&C trends (e.g., PhRMA, OIG, and data privacy regulations) and aligns the PDT R&D E&C program accordingly.
Supports the Takeda Digital Ethics and Data Privacy Programs at PDT R&D in collaboration with other leaders.
Minimum Requirements / Qualifications
Minimum Bachelor's degree
Minimum 8 years of experience in ethics and compliance in the pharmaceutical industry with a focus on R&D and Medical Affairs
Solid understanding and experience of Healthcare Compliance
Strong familiarity with and experience of all elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management)
Experience with laws, regulations and industry guidance affecting the pharmaceutical industry (e.g., IFPMA, EFPIA, OIG, PhRMA guidelines, SOPs, anti-bribery laws)
Experience managing compliance risks related to R&D and Medical Affairs (risk identification, controls, mitigation)
Project and change management skills
Proficient with Microsoft Office and collaboration tools
Strong interpersonal and communication skills with ability to advise business leaders
Demonstrated leadership and change-management abilities
Ability to lead projects and influence with and without authority
Strong data analysis and insights generation capabilities
Proven track record of delivering results on time while managing multiple priorities
Ability to build relationships with stakeholders and demonstrate executive presence
Ability to interpret business and regulatory information and legal advice
Ability to navigate complexity and ambiguity with pragmatic solutions
Curiosity, learning agility, and openness to innovative approaches
Strong operations, process-orientation, and capability to design and implement compliance processes
Preferred
Strong data analysis and storytelling with data skills to support decision-making
Experience using AI tools within Microsoft Office and collaboration platforms
Experience with AI and collaborative tools to enhance productivity
More about us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and patient support programs. Takeda is a patient-focused company focused on growth through life-changing work. We are Global Top Employer, offering stimulating careers in an inclusive, collaborative workplace committed to Better Health and a Brighter Future.
This position is classified as hybrid in Takeda's Hybrid and Remote Work policy.
Location and Compensation Location: Boston, MA
U.S. Base Salary Range: $208,200.00 - $327,140.00
The actual base salary offered depends on qualifications, experience, and location. U.S. based employees may be eligible for incentives and benefits including medical/dental/vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, and other well-being benefits.
EEO Statement Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants, without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or any other protected characteristic.
Locations: Boston, MA; USA - IL - Chicago
Job Type: Full-time, Exempt
Note: This page may include related job listings, but the core role description above reflects the Head of Ethics & Compliance for PDT R&D and Medical Affairs.
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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. This role operates in alignment with Takeda values and the PTRB decision-making model. Embedded in the business and a member of the PDT-R&D Extended and PDT E&C Leadership Teams, this leader guides 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 risk, ethics and compliance.
Guides the PDT R&D leadership team through effective, risk-based decision-making based on the regulatory environment and 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 to shape the PDT BU's organizational mindset around Takeda's Values and the PTRB model to embed values-based decision-making.
Acts as the PDT E&C R&D point of contact for the Global E&C R&D team and contributes to harmonization with E&C Global R&D and E&C USBU on common challenges (approval processes, SOPs, FMVs).
Reviews, assesses, and approves activities involving interactions with external stakeholders, clinical study protocols, and Medical Plans.
Leads 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, coordinating with PDT E&C team members and driving follow-up on risk mitigation measures.
Oversees mitigation and remedial action from monitoring, audit, and case management.
Leads E&C investigations for PDT R&D, coordinating with Global Investigations, HR, and Legal teams as needed.
Designs and establishes relevant E&C policies and procedures across PDT R&D and aligns with other E&C leaders for consistency and effectiveness.
Defines and delivers the E&C learning curriculum for PDT R&D, using the RITE model and within the PDT BU Learning Plan.
Ensures the E&C Learning Curriculum is embedded in annual learning offerings and facilitates E&C program sessions across the PDT R&D organization.
Uses the PDT BU Program Lifecycle Management (PLM) tool to assess the current state of controls and relevant elements of the E&C program for PDT R&D.
Contributes to global E&C program projects (Code of Conduct, Values initiatives, Policies and Procedures) and may lead global project teams affecting the Takeda-wide E&C Program.
Leads horizon scanning of evolving external E&C trends (e.g., PhRMA, OIG, and data privacy regulations) and aligns the PDT R&D E&C program accordingly.
Supports the Takeda Digital Ethics and Data Privacy Programs at PDT R&D in collaboration with other leaders.
Minimum Requirements / Qualifications
Minimum Bachelor's degree
Minimum 8 years of experience in ethics and compliance in the pharmaceutical industry with a focus on R&D and Medical Affairs
Solid understanding and experience of Healthcare Compliance
Strong familiarity with and experience of all elements of an ethics and compliance program (policies, risk management, learning, monitoring, case management)
Experience with laws, regulations and industry guidance affecting the pharmaceutical industry (e.g., IFPMA, EFPIA, OIG, PhRMA guidelines, SOPs, anti-bribery laws)
Experience managing compliance risks related to R&D and Medical Affairs (risk identification, controls, mitigation)
Project and change management skills
Proficient with Microsoft Office and collaboration tools
Strong interpersonal and communication skills with ability to advise business leaders
Demonstrated leadership and change-management abilities
Ability to lead projects and influence with and without authority
Strong data analysis and insights generation capabilities
Proven track record of delivering results on time while managing multiple priorities
Ability to build relationships with stakeholders and demonstrate executive presence
Ability to interpret business and regulatory information and legal advice
Ability to navigate complexity and ambiguity with pragmatic solutions
Curiosity, learning agility, and openness to innovative approaches
Strong operations, process-orientation, and capability to design and implement compliance processes
Preferred
Strong data analysis and storytelling with data skills to support decision-making
Experience using AI tools within Microsoft Office and collaboration platforms
Experience with AI and collaborative tools to enhance productivity
More about us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and patient support programs. Takeda is a patient-focused company focused on growth through life-changing work. We are Global Top Employer, offering stimulating careers in an inclusive, collaborative workplace committed to Better Health and a Brighter Future.
This position is classified as hybrid in Takeda's Hybrid and Remote Work policy.
Location and Compensation Location: Boston, MA
U.S. Base Salary Range: $208,200.00 - $327,140.00
The actual base salary offered depends on qualifications, experience, and location. U.S. based employees may be eligible for incentives and benefits including medical/dental/vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, and other well-being benefits.
EEO Statement Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants, without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or any other protected characteristic.
Locations: Boston, MA; USA - IL - Chicago
Job Type: Full-time, Exempt
Note: This page may include related job listings, but the core role description above reflects the Head of Ethics & Compliance for PDT R&D and Medical Affairs.
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