Associate Director, Data Validation Engineer

Responsibilities

• Develop clinical trial listings and visualizations specifications; build and oversee implementation of data review objectives/artifacts.
• Utilize and contribute to the development of libraries, functions, and transformation templates for reuse.
• Test, document programming tasks, and ensure compliance with trial master file requirements.
• Operate in compliance with Takeda SOPs while working with Clinical Data Operations and other functions.
• Provide clinical trial reporting expertise and leadership across global development programs and post‑marketing studies.
• Drive strategy with vendors to ensure compliance with regulations and standards.
• Partner with Data Configuration Engineer and Clinical Data Standards teams in developing standard and study‑specific data cleaning/quality checks, status metrics, visualizations, and monitoring reports.
• Organize clinical trial reporting activities for assigned studies and non‑clinical data cleaning.
• Foster collaboration with study teams (EDC Developers, Data Configuration, Clinical Operations, Data Managers, Statistical Programmers, Statisticians, and stakeholders).
• Assist with oversight of Functional Service Provider resource allocation and vendor partnerships.
• Possibly be responsible for line‑management of employees.
• Establish and maintain productive partnerships within CDOS, functional leaders across R&D, and third‑party service providers.
• Review, develop, maintain, and optimize processes to ensure compliance with regulatory and company requirements.
• Train and mentor staff on key activities and processes.
• Support the development of the clinical trial reporting talent base and identify development needs.
• Contribute to enablement of technology strategies such as Cross‑Function Data Review and Cleaning.
• Show influential strategic, execution, and delivery leadership within and outside Takeda with vendors and partners.
• Participate in oversight of technology vendors to ensure regulatory compliance and delivery of solutions.
• Represent the function during internal audits and regulatory inspections in collaboration with Quality Assurance and GCP & Operational Excellence.
• Confirm archival and inspection readiness of clinical trial reporting Trial Master File documents.
• Ensure compliance with learning curricula, corporate, and/or GxP requirements.

Qualifications

• BS/BA in a health‑related, life science, or technology‑related field.
• Minimum 8+ years of drug development experience.
• 6+ years of project management and leadership experience.
• Experience leading programming teams and influencing senior‑level management.
• Experience programming listings and/or visualizations with Veeva CDB, Elluminate, and JReview.
• Knowledge of clinical database systems (Metadata Rave, Veeva). Experience with CQL, SQL, SAS, R, or Python.
• Knowledge of data structures and data flow between clinical data management systems, vendor devices, and CDR.
• Experience managing vendors and implementing clinical technologies such as Elluminate, Veeva CDB, CluePoint, JReview, SAS, R, and RShiny.
• Operational experience in pharmaceutical drug development with exposure to clinical development and data operations (data review, regulatory submissions, safety updates).
• Knowledge of FDA and ICH regulations, industry standards, quality control principles, and best practices related to system validation, electronic records, signatures, and data privacy.
• Experience managing cross‑functional projects and developing successful partnerships.
• Strong communication (written and oral), leadership, decision‑making, influencing, negotiation, and project management skills.
• Remote work classification – currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

Compensation and Benefits

Massachusetts – Virtual. U.S. Base Salary Range: $154,400.00 – $242,550.00. U.S. employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time per calendar year, and up to 120 hours of paid vacation for new hires.

Job Type

Employee, Regular, Full‑time, Job Exempt Yes.

EEO Statement

Takeda is proud of 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.