Senior Director, Head of Clinical Program Quality & Excellence (TAU)
Takeda
August 20, 2026
Remote friendly (Cambridge, MA)
United States
$212,000 - $333,190 USD yearly
Clinical Research and Development
Senior Director, Head of Clinical Program Quality & Excellence (TAU)
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 with actionable insights for data-driven decisions
- Oversee investigations of serious breaches, scientific misconduct, and significant quality events; ensure 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
- Lead the Clinical Program Quality & Excellence team to embed proactive quality oversight, inspection readiness, and cross-functional issue resolution
- Partner with enterprise quality and continuous improvement teams to strengthen clinical trial delivery and pharmacovigilance systems
- Provide strategic counsel on complex quality challenges, priorities, initiatives, and resource planning
- Build and retain a high-performing team through leadership, talent development, succession planning, and accountability
Skills and Qualifications:
- Bachelor’s degree in a scientific/medical/health-related field (Master’s or PhD preferred)
- 12+ years in global pharmaceutical industry; 5+ years in Quality and/or Compliance supporting clinical development
- Advanced clinical development knowledge; deep GCP expertise
- Experience with clinical portfolio quality oversight, global quality systems, audit programs, regulatory inspections, and quality risk management
- Experience leading complex investigations and CAPA programs
- Expertise in risk-based quality management and audit strategies; health authority inspection/submission experience
- Knowledge of clinical trial quality systems and inspection readiness
- Experience leading enterprise transformation and managing global quality organizations; team-building experience
- Understanding of Pharmacovigilance, Medical Quality, and Clinical Quality processes and systems
Application Instructions:
- Submit an application via the “Apply” button.
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 with actionable insights for data-driven decisions
- Oversee investigations of serious breaches, scientific misconduct, and significant quality events; ensure 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
- Lead the Clinical Program Quality & Excellence team to embed proactive quality oversight, inspection readiness, and cross-functional issue resolution
- Partner with enterprise quality and continuous improvement teams to strengthen clinical trial delivery and pharmacovigilance systems
- Provide strategic counsel on complex quality challenges, priorities, initiatives, and resource planning
- Build and retain a high-performing team through leadership, talent development, succession planning, and accountability
Skills and Qualifications:
- Bachelor’s degree in a scientific/medical/health-related field (Master’s or PhD preferred)
- 12+ years in global pharmaceutical industry; 5+ years in Quality and/or Compliance supporting clinical development
- Advanced clinical development knowledge; deep GCP expertise
- Experience with clinical portfolio quality oversight, global quality systems, audit programs, regulatory inspections, and quality risk management
- Experience leading complex investigations and CAPA programs
- Expertise in risk-based quality management and audit strategies; health authority inspection/submission experience
- Knowledge of clinical trial quality systems and inspection readiness
- Experience leading enterprise transformation and managing global quality organizations; team-building experience
- Understanding of Pharmacovigilance, Medical Quality, and Clinical Quality processes and systems
Application Instructions:
- Submit an application via the “Apply” button.