Senior Director, Head of Clinical Program Quality & Excellence (TAU)

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda seeks a Senior Director, Head of Clinical Program Quality & Excellence to drive risk-based quality leadership across Therapeutic Area Unit clinical programs. You will guide governance, patient safety, data integrity, and regulatory readiness while partnering with enterprise quality teams to advance quality strategies and improve study delivery.

You will lead investigations, CAPA programs, and external inspections, shaping a culture of quality by design and accountability within a global

Qualifications

• Bachelor’s degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred.
• 12+ years in the global pharmaceutical industry, including 5+ years in Quality/Compliance supporting clinical development programs.
• Advanced knowledge of clinical research and development across the product lifecycle.

Responsibilities

• Drive risk-based quality strategies across clinical programs to ensure compliance, patient safety, and reduced development risk.
• Lead quality risk escalation, governance, and reporting with actionable insights for data-driven decisions.
• Oversee investigations of serious breaches, scientific misconduct, and significant quality events with root cause analysis and corrective actions.
• Ensure continuous inspection readiness and end-to-end regulatory compliance across clinical programs.
• Lead global GCP inspection strategy, including submission-related inspections and agency interactions as a quality SME.
• Develop and execute risk-based audit strategies to identify and mitigate quality risks across clinical development programs.
• Lead the Clinical Program Quality & Excellence team, embedding proactive quality oversight and cross-functional issue resolution.
• Provide strategic counsel on complex quality challenges, priorities, and resource planning to the Head of CPMQ.
• Build and retain a high-performing team through leadership, talent development, and accountability culture.

Skills

Quality management

GCP regulations

Regulatory inspections

Risk-based approach

Cross-functional leadership

Patient safety

Data integrity

CAPA programs

Audit programs

Governance

Education

Bachelor’s degree in a scientific/medical/health-related field

Master’s or PhD preferred

Job description

Job Description

About the Role As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive a risk-based quality management approach across the Therapeutic Area Unit, strengthening clinical program performance, regulatory confidence, and inspection readiness. You will provide quality leadership to key governance bodies, identify and mitigate emerging risks, and lead the Clinical Program Quality & Excellence team to embed operational excellence, patient safety, data integrity, and global regulatory compliance across clinical trial delivery. Additionally, you will help advance enterprise quality strategies, influence senior stakeholders, and foster a culture of quality by design, accountability, and continuous improvement. You will report into the Vice President, Head of Clinical, Pharmacovigilance and Medical Quality (CPMQ).

How You Will Contribute

• Drive risk-based quality strategies across assigned clinical programs to ensure compliance, patient safety, and reduced development risk
• Lead quality risk escalation, governance, and reporting, providing actionable insights to support timely, data-driven decisions
• Oversee investigations of serious breaches, scientific misconduct, and significant quality events, ensuring effective root cause analysis and sustainable corrective actions
• Ensure continuous inspection readiness and end-to-end compliance across clinical programs
• Lead global GCP inspection strategy, including submission-related inspections and regulatory agency interactions as a clinical quality SME
• Develop and execute risk-based audit strategies to identify, assess, and mitigate quality risks across clinical development programs
• Lead the Clinical Program Quality & Excellence team, embedding proactive quality oversight, inspection readiness, and cross-functional issue resolution across Study Execution Teams
• Partner with enterprise quality and continuous improvement teams to drive organizational learning and strengthen clinical trial delivery and pharmacovigilance systems
• Provide strategic counsel to the Head of CPMQ on complex quality challenges, priorities, initiatives, and resource planning
• Build, develop, and retain a high-performing team through strong leadership, talent development, succession planning, and a culture of accountability

Skills and Qualifications

• Bachelor’s degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred
• 12+ years of experience in the global pharmaceutical industry, including 5+ years in Quality and/or Compliance supporting clinical development programs
• Advanced knowledge of clinical research and development across the product lifecycle, including development, commercialization, and lifecycle management
• Deep expertise in GCP regulations, guidelines, and their practical application
• Experience in clinical portfolio quality oversight, global quality systems, audit programs, regulatory inspections, and quality risk management
• Experience leading complex investigations, remediation activities, and corrective and preventive action (CAPA) programs
• Expertise in developing and implementing risk-based quality management and audit strategies
• Experience supporting health authority inspections and submission-related regulatory activities
• Knowledge of clinical trial quality systems, inspection readiness, and compliance oversight frameworks
• Experience leading enterprise transformation initiatives, including quality system integration, operating model evolution, and outsourcing strategies
• Experience managing global quality organizations and developing high-performing teams
• Understanding of Pharmacovigilance, Medical Quality, and Clinical Quality processes and systems
• Commitment to patient safety, data integrity, scientific rigor, and regulatory compliance

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 - 500 U.S. Base Salary Range: $212,000.00 - $333,190.00 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.

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

Locations USA - MA - Cambridge - Kendall Square - 500 Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.