Associate Director, Clinical Data Configuration

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Job Description

GOALS:

The Associate Director, Clinical Data Configuration sits within R&D’s Testing, Innovation, and Data Enablement organization and provides leadership for clinical data configuration, transformation, ingestion, and visualization activities that support clinical trial conduct and development. This role leads Data Configuration Representatives and coordinates cross-functional matrix teams and vendors to define requirements, deliver high-quality work products to timelines, ensure inspection readiness, and advance standards, best practices (including transfer specifications), and related SOPs/training across platforms.

ACCOUNTABILITIES:

• Lead and develop a team of Data Configuration Representatives, setting priorities, allocating resources, and driving accountable delivery of data configuration and transformation capabilities that enable clinical trial execution across programs.
• Direct cross-functional/matrix teams and vendor delivery across data configuration, transformation, and visualization platforms; own timelines, quality, and outcomes while ensuring alignment to enterprise data strategy and clinical program needs
• Own stakeholder engagement with data engineering and clinical partners to define requirements, influence solution design, and ensure scalable, reusable data transformation and visualization capabilities across the portfolio.
• Provide end-to-end program leadership for data configuration and transformation initiatives, translating strategic priorities into executable plans and driving delivery across multiple concurrent programs in a complex, matrixed environment.
• Define, govern and promote standards, best practices, and data transfer specifications; own SOP development, implementation, and continuous improvement to ensure consistency, scalability, and compliance across platforms.
• Establish and enforce quality frameworks for internally delivered and vendor-supported outputs, ensuring data integrity, compliance, and adherence to enterprise standards across all deliverables
• Own inspection readiness for data configuration and transformation activities, ensuring audit‑ready processes, documentation, and controls that meet regulatory expectations and minimize organizational risk.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree (e.g., CS, statistics/biostatistics, math, biology/health-related) plus minimum 7 years relevant experience (or equivalent).
• Experience with EDC build/data management or EDC extraction/configuration; strong understanding of clinical data flow (CDMS, vendor devices, CDR).
• Familiarity with data cleaning tools (e.g. Veeva CDB, J Review, Elluminate).
• Visualization/configuration: experience designing visual objects and libraries; programming clinical trial visualization tools.
• Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM.
• Data/Integration: XML/standards repositories, APIs, ALS, MDR (preferred); ETL/ELT experience; familiarity with AWS/Databricks.
• Programming (preferred): One or more SQL, SAS, R or Python; R Shiny/Python app development.
• Tools/Ways of Working: Microsoft Office.
• Proven project leadership and project management skills including:  Initiative, deadline management, strong attention to detail, organization, time management; quick learner comfortable with new tech/systems; able to prioritize competing demands in a fast-paced environment.
• Demonstrated ability to lead projects/workgroups.
• Demonstrated ability to resolve issues independently and collaboratively; takes initiative; delivers to deadlines.
• Prior experience working effectively in a matrix environment;  experience mentoring/training others.

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:

U.S. Base Salary Range:

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.

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