Evidence Generation Operations & Compliance Director
Takeda
August 13, 2026
On-site
Cambridge, MA
$192,400 - $302,390 USD yearly
Operations
Objectives / Purpose
- Provides enterprise-level governance, operational standards and compliance leadership for Medical-led evidence generation activities.
- Serves as primary Medical Governance Office lead for evidence generation operations, ensuring governance, oversight, quality, risk management and inspection readiness; partners with R&D Quality Assurance as enterprise quality authority for applicable GxP research.
- Establishes governance expectations aligned to standards, laws/regulations, local requirements, industry codes and audit expectations; evolves governance using digital technologies, data transparency, automation and AI-enabled compliance.
- Ensures intake, risk assessment, documentation, oversight, escalation, close-out and audit-readiness expectations are followed.
Accountabilities
- Operational governance counterpart to R&D Quality Assurance for Medical-led evidence generation; implements enterprise quality expectations, GxP oversight, inspection readiness and risk-management approaches.
- Establishes/evolves governance standards for GxP and non-GxP evidence generation; defines pathways, decision rights, roles, escalation criteria and minimum documentation.
- Provides governance visibility via inventories, dashboards, risk indicators and performance metrics using data/automation/AI monitoring.
- Supports audit/inspection readiness, including issue escalation, remediation/CAPA follow-up and closure; defines governance expectations for external partners/vendors.
- Develops operating materials (intake questions, risk tools, checklists, playbooks, SOP inputs, training) and drives continuous improvement.
Education & Experience (Required)
- Degree in life sciences, pharmacy, medicine, public health, healthcare management, or related discipline.
- 10+ years in Medical Affairs, evidence generation/RWE operations, medical governance, research operations, quality, compliance, or related functions.
Skills / Competencies (Required/Preferred)
- Working knowledge of applicable laws/regulations, SOPs, data privacy, pharmacovigilance, data integrity and industry codes.
- Experience developing/improving governance frameworks and operating guidance; global/matrix experience preferred.
- Strong governance/risk-based systems thinking; ability to leverage digital tech, analytics and AI to improve governance and compliance monitoring.
- Ability to translate complex requirements into practical tools; excellent communication and stakeholder management.
Application instructions
- Apply via the “Apply” button; complete the employment application process.
- Provides enterprise-level governance, operational standards and compliance leadership for Medical-led evidence generation activities.
- Serves as primary Medical Governance Office lead for evidence generation operations, ensuring governance, oversight, quality, risk management and inspection readiness; partners with R&D Quality Assurance as enterprise quality authority for applicable GxP research.
- Establishes governance expectations aligned to standards, laws/regulations, local requirements, industry codes and audit expectations; evolves governance using digital technologies, data transparency, automation and AI-enabled compliance.
- Ensures intake, risk assessment, documentation, oversight, escalation, close-out and audit-readiness expectations are followed.
Accountabilities
- Operational governance counterpart to R&D Quality Assurance for Medical-led evidence generation; implements enterprise quality expectations, GxP oversight, inspection readiness and risk-management approaches.
- Establishes/evolves governance standards for GxP and non-GxP evidence generation; defines pathways, decision rights, roles, escalation criteria and minimum documentation.
- Provides governance visibility via inventories, dashboards, risk indicators and performance metrics using data/automation/AI monitoring.
- Supports audit/inspection readiness, including issue escalation, remediation/CAPA follow-up and closure; defines governance expectations for external partners/vendors.
- Develops operating materials (intake questions, risk tools, checklists, playbooks, SOP inputs, training) and drives continuous improvement.
Education & Experience (Required)
- Degree in life sciences, pharmacy, medicine, public health, healthcare management, or related discipline.
- 10+ years in Medical Affairs, evidence generation/RWE operations, medical governance, research operations, quality, compliance, or related functions.
Skills / Competencies (Required/Preferred)
- Working knowledge of applicable laws/regulations, SOPs, data privacy, pharmacovigilance, data integrity and industry codes.
- Experience developing/improving governance frameworks and operating guidance; global/matrix experience preferred.
- Strong governance/risk-based systems thinking; ability to leverage digital tech, analytics and AI to improve governance and compliance monitoring.
- Ability to translate complex requirements into practical tools; excellent communication and stakeholder management.
Application instructions
- Apply via the “Apply” button; complete the employment application process.