Remote Associate Director Data Validation Engineering

Job Description

Associate Director, Data Validation Engineer (DVE) role will work on Clinical Trial Reporting activities to deliver data listings and visualizations to facilitate the delivery of high‑quality data in a timely manner, leading to statistical analysis and submission to regulatory authorities. The role partners with Clinical Data Management and works with Takeda study teams to develop listings and visualizations specifications, build and/or oversee implementation of data review objectives and artifacts for clinical trials to support the overall data review plan. In addition, the role will utilize and contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study‑level validation tasks. DVEs are responsible for maintaining, testing and documenting programming tasks and ensuring compliance with trial master file requirements. The role operates in compliance with Takeda SOPs and processes while working closely with Clinical Data Operations Functions and others to enhance existing processes.

Accountabilities

• Provides clinical trial reporting expertise and leadership in support of global development programs as well as post‑marketing registration and non‑registration studies.
• Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
• Partners with Data Configuration Engineer and Clinical Data Standards teams in the development of standard and study‑specific data cleaning/quality checks, study status metrics, visualizations and monitoring reports.
• Organizes Clinical Trial Reporting activities for assigned clinical studies and non‑clinical data cleaning activities.
• Fosters and ensures close collaboration with study team members (e.g., EDC Developers, Data Configuration engineer, Clinical Operations, Clinical Data Managers, Statistical Programmers, Statisticians and other stakeholders) in the clinical data lifecycle and in the development/maintenance/governance of standard data review objectives and libraries.
• Assists with oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.
• Might be responsible for direct line management of employees.
• Establishes and maintains productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third‑party service providers.
• Responsible for the review, development, maintenance and optimization of processes to ensure that clinical trial reporting activities are in compliance with regulatory and company requirements.
• Training and mentoring staff on key activities and processes.
• Recognizes development needs and identifies/creates development opportunities within the team.
• Supports the development of the clinical trial reporting talent base and identifies development needs within the area of responsibility.
• Contributes to the enablement of technology strategies that support clinical program activities (e.g., Cross‑Function Data Review and Cleaning).
• Shows influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners.
• Participates in oversight of Global Development Operations technology vendors to ensure that they meet regulatory requirements and deliver accurate and efficient solutions to support therapeutic area management of global development programs.
• Represents function during internal audits and regulatory inspection in collaboration with Quality Assurance and GCP & Operational Excellence organizations.
• Confirms archival and inspection readiness of clinical trial reporting Trial Master File (TMF) documents.
• Ensures compliance with own Learning Curricula, corporate and/or GxP requirements.

Education & Competencies

• BS/BA in a health‑related, life science area or technology‑related fields.
• Minimum of 8+ years of drug development experience.
• 6+ years of project management and leadership experience.
• Previous experience leading programming teams and influencing senior‑level management and key stakeholders.
• Experience in programming listings and/or visualizations with Veeva CDB, Elluminate, or JReview.
• Knowledge of clinical database systems (Metadata Rave, Veeva) and 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 (e.g., Elluminate, Veeva CDB, CluePoint, Jreview, SAS, R, RShiny).
• Operational experience in pharmaceutical drug development with exposure to clinical development and data operations required for reporting clinical trial data (e.g., data review, regulatory submissions, safety updates).
• Knowledge of FDA and ICH regulations and industry standards and quality control principles as well as best practices related to computer system validation, electronic records and signatures, and data privacy.
• Experience managing cross‑functional projects and developing successful partnerships within and across functional areas.
• Strong communication (written and oral), leadership, decision‑making, influencing, negotiation, and project management skills.

Compensation and Benefits Summary

U.S. Base Salary Range: $154,400 – $242,550. The actual base salary offered may depend on qualifications, experience, skills, education, certifications, and location. U.S. employees may be eligible for short‑term and long‑term incentives, medical, dental, vision, 401(k) with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well‑being benefits. U.S. employees are eligible for up to 80 hours of sick time and up to 120 hours of paid vacation.

Location

Massachusetts – Virtual. The position is classified as remote in accordance with Takeda’s Hybrid and Remote Work policy.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.