Director, Clinical Data Management Operational Delivery

Job Description

Director, Clinical Data Management Operational Delivery – Remote

Reports to the Vice President, Head of Clinical Data Operations and Standards.

• Lead global implementation and adoption of new/enhanced Clinical Data Management (CDM) processes, tools and technology.
• Provide enterprise‑level oversight of data management delivery, study timeline standardization, and inspection readiness across assigned assets, therapeutic areas, and portfolios.
• Champion harmonization, change management, and user adoption of new processes and technology across regions, TAUs, and service providers.
• Act as Functional Process Owner and Expert within Takeda’s continuous improvement framework.
• Serve as lead CDM standards governance representative and partner with Business Process Owners to ensure compliance and user‑focused documentation.
• Coordinate with CDM Leadership Team to set initiative priorities and mitigate identified risks.
• Provide expert functional support guidance in audit readiness and operational excellence initiatives.
• Maintain an enterprise view of study timelines and status across the study lifecycle for data management activities.
• Develop and maintain resourcing models, algorithmic forecasting, and vendor partnership management.

• Establish and maintain a CDM Project Management framework for enterprise oversight.
• Implement mechanisms for risk and milestone tracking and reporting to cross‑functional stakeholders.
• Oversee CDM inspection readiness and coordinate with external regulatory entities.
• Represent the function in external professional initiatives and organizations (e.g., SCDM, CDISC, DIA).
• Identify, recommend, and drive changes based on industry best practices and regulatory trends.
• Perform other duties as assigned.

• Bachelor’s or Master’s degree (or international equivalent) in a relevant field.
• 10+ years of data management experience in the pharmaceutical industry.
• 7+ years of vendor relationship and alliance partnership management experience.
• 5+ years of line‑level management experience.
• Strong knowledge of FDA and ICH regulations applicable to data capture and data management processes.
• Proficiency with relational databases, electronic data capture systems, and data warehouse technologies.
• Advanced understanding of the drug development lifecycle and cross‑functional interfaces within data management.
• Excellent verbal, written communication, negotiation, and problem‑solving skills.
• Demonstrated ability to lead in dynamic, ambiguous environments and to drive innovation.

U.S. Base Salary Range: $177,000 – $278,080 per year.

Eligible for short‑term and long‑term incentives, medical, dental, vision, 401(k), disability coverage, life insurance, tuition reimbursement, volunteer time off, company holidays, and well‑being benefits.

Paid sick time up to 80 hours per calendar year; new hires accrue up to 120 hours paid vacation.

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.

Massachusetts – Virtual