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

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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.

For information about our benefits, please click here .

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 - 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. An employer who violates this law shall be subject to criminal penalties and civil liability.