Associate Director, Clinical Data Enablement

Associate Director, Clinical Data Enablement Join us as an Associate Director, Clinical Data Enablement based remotely reporting to the Director, Clinical Data Engineering. This role will lead clinical data delivery and ingestion, oversee end‑to‑end processes from source transfers to data lake and downstream consumption, and provide leadership through mentoring, frameworks, and operational excellence. Key Responsibilities Own end‑to‑end clinical data delivery from source transfers through ingestion, review platforms, lake/warehouse, and 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, and 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 and maintain transfer specifications, 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. Qualifications 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 and 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, QC rules, 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 (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. Strong cross‑functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming). Detail‑oriented, highly organized, collaborative, self‑directed, proactive problem‑solver who can manage recurring operational workloads while driving issues to closure and preventing recurrence. Compensation and Benefits Location: Massachusetts - Virtual Base Salary Range: $154,400.00 – $242,550.00 Eligible for short‑term and long‑term incentives (U.S. based employees). Medical, dental, 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 accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr Takeda Pharmaceuticals International GmbH