Associate Director, Clinical Data Enablement

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Clinical Data Enablement based remotely reporting to the Director, Clinical Data Engineering.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:   

The Associate Director, Clinical Data Enablement will lead Clinical Data Delivery & Ingestion. Owns end-to-end clinical data delivery across ingestion, integration, operational monitoring, and downstream consumption. This role leads the delivery of data into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) as well as enterprise data lake/warehouse ecosystems, ensuring data is review-ready, reliable, traceable, and compliant. The role also provides delivery leadership by leading/mentoring FSPs and driving scalable frameworks, standards, and operational excellence.

Accountabilities:

• Own end-to-end clinical data delivery from source transfers to ingestion to review platforms to lake/warehouse → downstream exports, ensuring stable, performant, and traceable operations.
• Define delivery plans, prioritize work, and drive execution across multiple concurrent studies and vendor feeds; manage delivery risks, dependencies, and release schedules.
• Establish and manage SLAs/OLAs, delivery KPIs, and service health reporting (timeliness, completeness, quality, incident trends).
• Build and evolve a reusable ingestion/integration framework (metadata-driven mappings, standardized templates, reusable QC rules, automation utilities, runbooks) to accelerate onboarding and improve consistency across studies/vendors.
• Automate operational workflows (scheduling, exception handling, automated quality checks) to improve reliability, repeatability, and cycle time.
• Lead design and operation of clinical data pipelines across data lake/warehouse environments, including build/run/monitor/troubleshoot responsibilities.
• Build and scale cloud-based ETL/ELT capabilities (AWS/Azure) for efficient ingestion, transformation, orchestration, and delivery to downstream data products and analytics needs.
• Provide SME troubleshooting and standardize fixes (documentation/reusable controls).
• Define/maintain transfer specs, mappings, acceptance criteria, and reconciliation with vendors and stakeholders.
• Align downstream outputs/exports with SDTM/Stats/Analytics/CDP needs (format/cadence).
• Ensure GxP/CSV compliance (documentation/traceability/audit readiness) and embed data integrity (ALCOA+) controls with Quality/Compliance/IT.
• Lead and mentor junior staff and FSPs through technical guidance, delivery planning, code/config reviews, and establishing team standards and best practices.
• Promote consistent ways of working (documentation, runbooks, onboarding playbooks, design patterns) to scale delivery and reduce key-person dependency.

EDUCATION AND EXPERIENCE:

• BS/BA (or equivalent) plus 7+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support, ideally supporting clinical data review and recurring study/vendor transfers.
• Experience ingesting data into Veeva CDB, Elluminate, and/or JReview (