Senior Director, Head of Clinical Program Quality & Excellence (TAU) Cambridge, MA Category: Quality

By 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 DescriptionAbout the RoleAs 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 ContributeDrive risk-based quality strategies across assigned clinical programs to ensure compliance, patient safety, and reduced development riskLead quality risk escalation, governance, and reporting, providing actionable insights to support timely, data-driven decisionsOversee investigations of serious breaches, scientific misconduct, and significant quality events, ensuring effective root cause analysis and sustainable corrective actionsEnsure continuous inspection readiness and end-to-end compliance across clinical programsLead global GCP inspection strategy, including submission-related inspections and regulatory agency interactions as a clinical quality SMEDevelop and execute risk-based audit strategies to identify, assess, and mitigate quality risks across clinical development programsLead the Clinical Program Quality & Excellence team, embedding proactive quality oversight, inspection readiness, and cross-functional issue resolution across Study Execution TeamsPartner with enterprise quality and continuous improvement teams to drive organizational learning and strengthen clinical trial delivery and pharmacovigilance systemsProvide strategic counsel to the Head of CPMQ on complex quality challenges, priorities, initiatives, and resource planningBuild, develop, and retain a high-performing team through strong leadership, talent development, succession planning, and a culture of accountabilitySkills and QualificationsBachelor’s degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred12+ years of experience in the global pharmaceutical industry, including 5+ years in Quality and/or Compliance supporting clinical development programsAdvanced knowledge of clinical research and development across the product lifecycle, including development, commercialization, and lifecycle managementDeep expertise in GCP regulations, guidelines, and their practical applicationExperience in clinical portfolio quality oversight, global quality systems, audit programs, regulatory inspections, and quality risk managementExperience leading complex investigations, remediation activities, and corrective and preventive action (CAPA) programsExpertise in developing and implementing risk-based quality management and audit strategiesExperience supporting health authority inspections and submission-related regulatory activitiesKnowledge of clinical trial quality systems, inspection readiness, and compliance oversight frameworksExperience leading enterprise transformation initiatives, including quality system integration, operating model evolution, and outsourcing strategiesExperience managing global quality organizations and developing high-performing teamsUnderstanding of Pharmacovigilance, Medical Quality, and Clinical Quality processes and systemsCommitment to patient safety, data integrity, scientific rigor, and regulatory complianceTakeda Compensation and Benefits SummaryWe 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:$212,000.00 - $333,190.00The 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 StatementTakeda 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.LocationsUSA - MA - Cambridge - Kendall Square - 500Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt 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.