Associate Director, Clinical Data Configuration

About the role

Join Takeda as an Associate Director, Clinical Data Configuration, based remotely and reporting to the Director, Data Configuration Engineer. This role 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.

Responsibilities

• 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.
• Engage 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.

Requirements

• Bachelor’s degree (e.g., Computer Science, statistics/biostatistics, math, biology/health-related) plus minimum 7 years of 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.
• Experience with data/integration XML/standards repositories, APIs, ALS, MDR (preferred); ETL/ELT experience; familiarity with AWS/Databricks.
• Programming skills in one or more of SQL, SAS, R, or Python; R Shiny/Python app development (preferred).
• Proficient with Microsoft Office.
• Proven project leadership and project management skills, including initiative, deadline management, strong attention to detail, organization, and time management.
• Quick learner comfortable with new technology/systems; able to prioritize competing demands in a fast-paced environment.
• Demonstrated ability to lead projects/workgroups and resolve issues independently and collaboratively.
• Takes initiative; delivers to deadlines.
• Prior experience working effectively in a matrix environment; experience mentoring/training others.

Pay

For Location: Massachusetts - Virtual U.S., the base salary range is $154,400.00 - $242,550.00. The actual base salary offered may depend on factors such as qualifications, relevant experience, specific skills, education, certifications, and location.

Benefits

• Eligibility for short-term and/or long-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation per calendar year.

Schedule

Full time, exempt position.