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

Regulatory Toolkit; Cambridge (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 management across global clinical programs. You will lead a team to ensure patient safety, data integrity, and regulatory compliance while engaging governance bodies and senior stakeholders.

The role requires 12+ years in pharma with 5+ years in quality/compliance, deep GCP knowledge, and a track record of inspection readiness and CAPA leadership. Cambridge, MA; full-time, on-site.

Qualifications

• Bachelor's degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred.
• 12+ years in global pharma, with 5+ years in Quality/Compliance for clinical development.
• Deep knowledge of clinical research and development and GCP regulations.

Responsibilities

• Drive risk-based quality strategies to ensure patient safety and regulatory compliance.
• Lead quality risk escalation, governance, and reporting with actionable insights.
• Oversee investigations of serious breaches and CAPA programs with root-cause analysis.
• Ensure inspection readiness and end-to-end compliance across clinical programs.
• Lead global GCP inspection strategy including submissions and agency interactions.
• Develop and execute risk-based audit strategies across clinical development.
• Lead the team embedding proactive quality oversight and cross-functional issue resolution.
• Partner with enterprise quality to strengthen trial delivery and pharmacovigilance systems.
• Provide strategic counsel on complex quality challenges and resource planning.
• Build and retain a high-performing team with strong leadership.

Skills

Quality leadership

GCP knowledge

Regulatory inspections

Risk management

Data integrity

Patient safety

Education

Bachelor's in science

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

USA - MA - Cambridge - Kendall Square - 500

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job 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.