Director, Clinical Data Management Operational Delivery

Responsibilities

• Lead global implementation and adoption of new/enhanced Clinical Data Management processes, ways of working, and technology (e.g., CFDR).
• Provide enterprise‑level oversight of data management delivery, study timeline standardization, and inspection readiness across assigned assets, TAUs, and portfolios.
• Lead implementation of new and enhanced processes, ways of working and technology implementation projects within clinical data management.
• Partner across CDSO and CDOS to ensure roll‑out.
• Identify risks and work with cross‑functional leaders to mitigate.
• Coordinate with the CDM Leadership Team to set initiative priorities.
• Partner with Global Development Compliance to implement and monitor rollout of new processes, tech, and ways of working.
• Champion harmonization, change management and user adoption efforts across regions, TAUs and service providers.
• Serve as Functional Process Owner and Expert within the continuous improvement framework.
• Maintain and update process documentation to ensure regulatory compliance and alignment with end‑user needs.
• Lead the champion/SME network (e.g., CFDR) to embed process and technology knowledge & proficiency in CDM members.
• Drive significant business change within CDM and across the broader organization to ensure successful execution of the CDM strategy and operating models.

• Bachelor’s or Master’s degree (or equivalent) preferred.
• 10+ years of data management experience in the pharmaceutical industry.
• At least 7 years of managing vendor relationships and alliance partnerships.
• Excellent verbal and written communication skills, ability to influence at all levels.
• Seasoned leader with talent development skills and ability to perform in a dynamic environment.
• Exceptional interpersonal, negotiation and problem‑solving skills.
• Leadership that excels under pressure, ambiguity, frequent change or unpredictability.
• Entrepreneurial and innovative mindset, willingness to take measured risks and challenge the status quo.
• 5+ years of line management experience (second‑level management preferred).
• Expert knowledge of FDA, ICH regulations and industry standards applicable to data capture and data management.
• Experience with budget planning and relational databases.
• Strong knowledge of electronic data capture, data warehouse technologies, and cross‑functional interfaces in drug development.

Location:

Remote.

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.