Associate Director, Clinical Data Configuration

Join us as an Associate Director, Clinical Data Configuration based remotely, reporting to the Director, Data Configuration Engineer. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. We empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and foster an inclusive, collaborative workplace.

About the role

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, and related SOPs/training across platforms.

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.
• 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.

Requirements

• 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 of SQL, SAS, R, or Python; R Shiny/Python app development.
• 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 and resolve issues independently and collaboratively; takes initiative; delivers to deadlines.
• Prior experience working effectively in a matrix environment; experience mentoring/training others.

Benefits

• 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.

Pay

For Location: Massachusetts - Virtual U.S. Base Salary Range: $154,400.00 - $242,550.00. 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, 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.

Schedule

Full time, exempt position.