Evidence Generation Operations & Compliance Director

Takeda•Cambridge, MA

3d•Onsite

About The Position

Provides enterprise-level governance, operational standards and compliance leadership for Medical-led evidence generation activities within Global Medical. Serves as the primary Medical Governance Office lead for evidence generation operations, ensuring consistent governance, oversight, quality, risk management and inspection readiness across Medical-led research activities while partnering with R&D Quality Assurance as the enterprise quality authority for applicable GxP research activities. Establishes clear governance expectations aligned with Takeda standards, applicable laws and regulations, local requirements, industry codes, enterprise quality frameworks and audit expectations, while continuously evolving governance approaches to leverage digital technologies, data transparency, automation and AI-enabled compliance capabilities. Ensures applicable evidence generation activities follow clear intake, risk assessment, documentation, oversight, escalation, close-out and audit-readiness expectations. Partners with Global Medical Evidence Generation, R&D Quality Assurance, Medical teams, Ethics & Compliance, Legal, Regulatory, Pharmacovigilance, Digital/DD&T, and other experts as needed to support patient-centric, scientifically robust and compliant execution.

Requirements

Degree in life sciences, pharmacy, medicine, public health, healthcare management, or related discipline required
10+ years of relevant experience in Medical Affairs, evidence generation/RWE operations, medical governance, research operations, quality, compliance or related functions.
Experience supporting governance or operational oversight of Medical-led evidence generation activities, including process standards, documentation requirements, risk assessment, external partner oversight, issue management and audit readiness.
Working knowledge of applicable laws, regulations, company SOPs, data privacy, pharmacovigilance considerations, data integrity expectations and relevant industry codes.
Experience developing or improving governance frameworks, SOPs, operating guidance, committee processes, dashboards, tracking tools, documentation standards or cross-functional ways of working.
Strong governance, risk-based thinking and systems-thinking capability, with the ability to anticipate evolving regulatory, quality, technological and AI-related implications for evidence generation operations.
Strong understanding of quality systems, risk-based oversight methodologies and the application of enterprise quality frameworks within evidence generation and research operations environments.
Demonstrated ability to leverage digital technologies, advanced analytics and emerging AI capabilities to improve governance effectiveness, operational efficiency, compliance monitoring and decision-making.
Ability to translate complex requirements into simple, practical tools and guidance.
Excellent communication, influence and stakeholder-management skills across cultures, functions and seniority levels.
Executive communication skills, with the ability to frame status, implications, risks and recommendations clearly.
Ability to balance compliance rigor with operational practicality while maintaining strong patient, scientific, quality, privacy and safety safeguards.
High attention to detail, clarity and documentation quality, with sound judgment in sensitive or reputationally important situations.
Ability to support transformation and change adoption in a patient-first, science-led and ethically grounded Medical culture.

Nice To Haves

Experience working in global, regional or matrix environments with multiple stakeholders and varied local requirements preferred.

Responsibilities

Serve as the operational governance counterpart to R&D Quality Assurance for Medical-led evidence generation activities, ensuring appropriate implementation of enterprise quality expectations, GxP oversight principles, inspection readiness practices and risk-management approaches while aligning Medical operational requirements with enterprise quality frameworks.
Establish and evolve enterprise governance standards for Medical-led evidence generation activities, ensuring consistent quality, transparency, oversight and compliance across both GxP and non-GxP evidence generation modalities, with direct accountability for governance frameworks supporting real-world evidence activities not subject to enterprise GxP quality governance.
Define governance pathways, decision rights, roles and responsibilities, escalation criteria and minimum documentation requirements for evidence generation activities within the Medical Governance Office (MGO) remit.
Provide operational governance oversight and maintain governance visibility through inventories, status tracking, dashboards, risk indicators and performance metrics. Leverage data, automation and AI-enabled monitoring capabilities to enhance transparency, identify emerging risks and support proactive governance decision-making.
Partner with Global Medical Evidence Generation, R&D Quality Assurance, Ethics & Compliance, Legal, Regulatory, Pharmacovigilance and Digital/DD&T to align governance expectations with applicable laws and regulations, quality frameworks, Takeda SOPs, data privacy, data integrity, AI governance requirements and industry-code expectations.
Support audit and inspection readiness, including documentation standards, quality checks, issue escalation, remediation/CAPA follow-up and closure, while coordinating closely with R&D Quality Assurance for activities subject to enterprise quality oversight and inspection frameworks.
Define minimum governance expectations for external partners and vendor-supported activities, including appropriate oversight, documentation, conflict-of-interest and issue-escalation requirements.
Develop practical operating materials, including intake questions, risk-assessment tools, checklists, governance playbooks, SOP/standard inputs and training materials.
Build capability and drive continuous improvement through guidance, onboarding, governance forums and recommendations to the Medical leadership.
Partner closely with Global Evidence Generation Strategy & Operations and Clinical Science and Study Operations Group to identify opportunities to modernize evidence generation operations through emerging technologies, intelligent workflow design, advanced analytics and responsible AI solutions that improve compliance, efficiency, documentation quality, oversight effectiveness and user experience.
Builds trusted partnerships with Global Medical, Evidence Generation/RWE, Therapeutic Areas, regional/local Medical teams and relevant functional experts.
Champions a culture of continuous improvement, innovation and responsible adoption of digital and AI-enabled capabilities, ensuring governance and compliance frameworks evolve alongside emerging evidence generation approaches and technologies.
Influences without direct authority across geographies and levels of seniority, creating alignment around evidence generation governance standards and ways of working.
Translates complex governance and compliance requirements into clear, usable standards, tools and guidance.
Supports change adoption and models Takeda's values, strengthening a patient-first, science-led and accountable Medical governance culture.
Partners with Global Medical Evidence Generation to organize evidence generation governance standards and process guidance, drive related SOP updates and revision processes,, and supporting controls within the MGO mandate, including governance frameworks for non-GxP real-world evidence activities and implementation of applicable enterprise quality expectations for GxP-governed research activities.
Recommends governance pathways, documentation, oversight and escalation needs based on the nature and complexity of each activity.
Determines when senior input or expert review is needed for complex activities, ownership boundaries, safety/privacy concerns, policy questions or audit-readiness gaps.
Advises the Medical leadership on governance risks, compliance and process issues and improvement opportunities.
Evaluates and recommends new governance, digital, automation and AI-enabled capabilities to strengthen compliance monitoring, risk management, operational efficiency, documentation quality and inspection readiness.