Associate Director, Clinical Data Enablement

Takeda•USA - MA - Virtual, MA

22h•$154,400 - $242,550•Remote

About The Position

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.

Requirements

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 (or comparable clinical data review systems).
Strong understanding of end-to-end ingestion concepts including data contracts/specifications, refresh cadence, incremental vs full loads, controlled reprocessing, reconciliation, and traceable lineage.
Ability to design/execute automated QC/validation checks, completeness/timeliness verification, and reconciliation routines to ensure datasets are review-ready.
Hands-on experience with CSV, JSON, XML and file-based and/or API-based integrations; familiarity with secure transfer patterns (e.g., SFTP/managed file transfer concepts).
Strong SQL skills; working proficiency in Python (preferred) or similar scripting to automate ingestion, QC, parsing, and operational tasks.
Demonstrated ability to build or extend reusable ingestion components (metadata-driven mappings, templates, reusable QC rules, standard runbooks).
Experience building/using monitoring for transfers and pipelines (e.g., expected vs received, timeliness/completeness checks, alerting, incident triage, reruns, KPI/SLA reporting).
Working knowledge of common clinical sources such as EDC, CTMS, and vendor domains (e.g., labs, eCOA/ePRO, imaging, safety) and how those feeds typically arrive and change over time.
Understanding of downstream consumption needs (data review workflows, exports to CDM/analytics/programming) and ability to support stable, well-documented exports.
Strong documentation discipline (specs, mappings, runbooks, issue logs) and comfort operating in controlled/regulated environments.
Exposure to GxP/CSV expectations, change control, and maintaining audit-ready operational evidence (as applicable to the organization/process).
Strong cross-functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming).
Detail-oriented, highly organized, Strong collaboration and communication; organized, self-directed, proactive problem-solver and able to manage recurring operational workloads while driving issues to closure and preventing recurrence.

Responsibilities

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.