Job Posting
Evidence Generation Operations & Compliance Director
Cambridge, Massachusetts Job ID R0185069 Category Medical Affairs Subcategory Commercial Business Unit Global Portfolio Division Job Type Full timeBy 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.
Job Description
OBJECTIVES / PURPOSE
- 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.
ACCOUNTABILITIES
- 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.
DIMENSIONS AND ASPECTS
- Provides enterprise governance standards and governance oversight for assigned Medical-led evidence generation activities across Global, US, Oncology and International Medical.
- Operates in a regulated, matrixed and multi-country environment with varying local regulations, industry codes, privacy requirements, pharmacovigilance expectations and Medical Affairs maturity.
- Acts as a senior governance and operational partner, helping Medical teams apply consistent standards in a practical, risk-based and audit-ready way while serving as a key interface between Medical Evidence Generation, R&D Quality Assurance and enterprise governance functions.
- Balances scientific rigor, patient benefit, transparency, compliance, data integrity, operational agility and process simplicity.
- Enables consistent, defensible and auditable Medical-led evidence generation without taking ownership of Therapeutic Area evidence strategy, research questions or scientific study design.
- Operates in a rapidly evolving environment where advances in data science, digital platforms, analytics, automation and artificial intelligence are reshaping evidence generation methodologies, compliance expectations and governance models.
Leadership
- 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.
Decision-making and Autonomy
- 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.
- Exercises judgment under ambiguity while ensuring activities remain aligned with Takeda's ethical standards, enterprise policies, applicable requirements and audit expectations.
- Evaluates and recommends new governance, digital, automation and AI-enabled capabilities to strengthen compliance monitoring, risk management, operational efficiency, documentation quality and inspection readiness.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Education & Experience
- 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.
- Experience working in global, regional or matrix environments with multiple stakeholders and varied local requirements preferred.
Competencies & Skills
- 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.
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:
USA - MA - Cambridge - Kendall Square - 500U.S. Base Salary Range:
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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
USA - MA - Cambridge - Kendall Square - 500Worker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesIt 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.
