What are the responsibilities and job description for the Director, Clinical Program Quality & Excellence (CPQE), TAU position at BioSpace?
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Job Description
About the Role
As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients. You will influence key portfolio decisions by providing insights on emerging risks, critical quality issues, and mitigation strategies, while leading inspection readiness across Study Execution Teams and ensuring compliance with global GCP and regulatory expectations. Through strong partnership with senior stakeholders, you will champion a culture of quality by design, accountability, and scientific rigor that protects patient safety, ensures data integrity, and enables successful regulatory submissions worldwide. You will report into the Senior Director, CPQE.
How You Will Contribute
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
$177,000.00 - $278,080.00
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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
LocationsUSA - MA - Cambridge - Kendall Square - 500
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull 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.
Job Description
About the Role
As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients. You will influence key portfolio decisions by providing insights on emerging risks, critical quality issues, and mitigation strategies, while leading inspection readiness across Study Execution Teams and ensuring compliance with global GCP and regulatory expectations. Through strong partnership with senior stakeholders, you will champion a culture of quality by design, accountability, and scientific rigor that protects patient safety, ensures data integrity, and enables successful regulatory submissions worldwide. You will report into the Senior Director, CPQE.
How You Will Contribute
- Lead quality management for assigned asset-level clinical programs, developing and implementing proactive, risk-based quality strategies that drive compliance and reduce program risk
- Provide strategic oversight of quality risks, issues, and mitigation plans, escalating key insights to governance bodies to support data-driven, patient-centered decision making
- Direct investigations into Serious Breaches (GCP), Scientific Misconduct, and other significant quality events, applying robust root cause analysis to enable effective resolution and prevention of recurrence
- Drive inspection readiness across assigned clinical programs, ensuring sustainable compliance and quality oversight are embedded throughout the clinical trial lifecycle
- Shape and execute global GCP inspection strategies, leading preparation for submission-related inspections and serving as a subject matter expert during regulatory interactions
- Develop and implement risk-based audit strategies that enable early identification of quality concerns and proactive mitigation of clinical program risks
- Mentor and support CPQ team members aligned to Study Execution Teams (SETs), strengthening quality oversight capabilities and embedding real-time inspection readiness through proactive compliance and documentation excellence.
- Foster cross-functional collaboration to drive timely investigation and resolution of quality events while promoting a culture of continuous improvement
- Contribute to R&D Quality continuous improvement initiatives for Clinical Trial Delivery and PV Systems by sharing insights, lessons learned, and best practices across clinical programs
- Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)
- Minimum of 10 years of progressive experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development programs
- Advanced expertise across the clinical development lifecycle, from R&D through commercialization and lifecycle management, with deep, hands‑on knowledge of GCP regulations and guidelines
- Experience in quality leadership roles, including quality systems oversight, clinical portfolio governance, audit programs, global regulatory inspection management, and complex investigation and remediation activities
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
$177,000.00 - $278,080.00
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.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
LocationsUSA - MA - Cambridge - Kendall Square - 500
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull 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.
Salary : $177,000 - $278,080