Associate Director, Clinical Data Configuration

Job Description

Associate Director, Clinical Data Configuration – based remotely, reporting to the Director, Data Configuration Engineer. Join a patient‑focused, innovation‑driven company that empowers people to work toward their potential through life‑changing work.

The Associate Director 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.

• 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.

• 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).
• Experience designing visual objects and libraries; programming clinical trial visualization tools.
• Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM.
• Experience with 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.
• Proven project leadership and project management skills – 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/work groups, resolve issues independently, and collaborate; takes initiative and delivers to deadlines.
• Prior experience working effectively in a matrix environment; experience mentoring/training others.

Location:

Massachusetts – Virtual U.S.
Base Salary Range: $ – $ (actual offer may vary with qualifications, experience, and location.)

U.S. employees may be eligible for short‑term and long‑term incentives, medical, dental, vision insurance, 401(k) with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, sick time (up to 80 hours per calendar year) and paid vacation (up to 120 hours new hires). All other benefits are consistent with U.S. standards for comparable roles.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment…