Director, Clinical Data Management Operational Delivery

About the role

The Director, Clinical Data Management Operational Delivery is responsible for leading the implementation and adoption of new/enhanced Clinical Data Management (CDM) processes, ways of working, and technology (e.g., CFDR) while providing enterprise-level oversight of data management (DM) delivery, study timelines standardization, and inspection readiness across assigned assets/TAUs/portfolios.

Responsibilities

• Lead global implementation and adoption of new/enhanced Clinical Data Management (CDM) processes, ways of working, and technology (e.g., CFDR).
• Provide enterprise-level oversight of data management (DM) delivery, study timelines standardization, and inspection readiness across assigned assets/TAUs/portfolios.
• Identify risks and work with CDM LT and other cross-function leaders to mitigate.
• Coordinate with CDM LT to set initiative priorities.
• Partner with Global Development Compliance (GDC) 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.
• Partner with process Business Process Owner (BPO), GDC, and BSO to ensure controlled and business-controlled process documents are complete, meet regulatory compliance (as applicable), and are optimized for end user needs.
• Champion champion/SME network (e.g., CFDR) to embed process and tech knowledge & proficiency in CDM functional members.
• Lead and/or participate in process excellence and/or initiatives through operational implementation.
• Partner across TAUs and roles to ensure consistent approach and implementation of process and ways of working.
• Serve as lead CDM standards governance representative.
• Serve as lead CDM stakeholder and partner with BSO to ensure technology aligns with CDM roadmap.
• Lead and/or participate in process excellence and/or initiatives through operational implementation.
• Partner across TAUs and roles to ensure consistent approach and implementation of process and ways of working.
• Serve as lead CDM standards governance representative.
• Serve as lead CDM stakeholder and partner with BSO to ensure technology aligns with CDM roadmap.
• Drive significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models.
• Provide DM expertise in support of CDM operating model for TAU, program(s), and/or portfolio level.
• Develop and maintain CFDR stakeholder management across SET roles to support operational excellence and escalation activities.
• Provide expert functional support guidance in audit readiness.
• Represent function in external professional initiatives and organizations (e.g., SCDM, CDISC, DIA) to identify industry best practice and increase the visibility of Takeda.
• Identify, recommend, and drive changes in industry best practices and/or regulatory trends within and across TAUs.

Qualifications

• Bachelor’s/MS Degree or international equivalent preferred, or equivalent combination of education, training and experience.
• 10+ years of data management experience in the pharmaceutical industry.
• Expert knowledge and successful experience managing vendor relationships and alliance partnerships with at least 7 years experience in this area.
• 5+ years of line management experience (prior second-level management experience preferred).
• Excellent verbal/written communication skills and ability to influence at all levels across functions and build effective relationships.
• Seasoned leader with a passion for people development and an ability to perform in a highly dynamic environment.
• Outstanding interpersonal skills, exceptional negotiation and problem-solving skills.
• Focused and versatile leader who excels under pressure, ambiguity, frequent change, or unpredictability.
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Experience with budget planning.
• Strong knowledge of relational databases and experience using multiple clinical data management systems.
• Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

Skills

• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Strong knowledge of relational databases and experience using multiple clinical data management systems.
• Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
• Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

Benefits

Takeda offers a comprehensive compensation and benefits package, including:

• U.S. based employees may be eligible for short-term and/or long-term incentives.
• Medical, dental, and 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.

U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to 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.