Senior Director, Clinical Data Management

Objectives/Purpose

Responsible for the effective leadership, strategic planning, and oversight for one or several Therapeutic Area Units (TAUs) and/or operational units within Clinical Data Management (CDM). Sets the vision, direction, and strategy for area(s) of responsibility and actively contributes to and aligns with the overall CDM, Innovation & Data (I&D) and Global Development Office (GDO) strategies and operating models. Leads operationalization activities to ensure on time, high quality and within budget delivery that enable successful trial data analyses for Takeda to deliver medicines to patients faster. Champions CDM operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CDM capabilities. Is an accomplished people and relationship manager, establishing and maintaining productive partnerships within CDM, functional leaders across R&D, and third-party service providers.

Accountabilities

• Accountable for the timely and high-quality delivery of clinical databases for assigned TAUs, ensuring fitness of purpose and compliance to applicable regulations and SOPs.
• Proactively drives quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and applicable standards.
• Leads the development of robust strategies for DM resourcing, outsourcing, technologies and risk management to enable more efficient management, collaboration, and pro-active decision making.
• Contributes to the overall strategic direction of Takeda R&D and the role of clinical data management in maintaining the company’s competitive advantage and delivering on Takeda’s business objectives.
• Supports the Head of Clinical Data Management in leading cross-functional efforts to build out processes and infrastructure necessary to internalize key CDM capabilities and optimize overall operational delivery.
• Represents CDM on key cross-functional initiatives.
• Drives significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models.
• Champions harmonization efforts across regions, TAUs and service providers.
• Recruits, selects, develops, manages, motivates, coaches and appraises the performance of direct reports.
• Builds team commitment to goals, and creates a positive and productive culture within the team.
• Ensures appropriate training and acts as a leader and mentor for all DM globally.
• Leads the development of SOPs, procedural documentation and continuous process improvement activities in collaboration with DM leadership team.
• Identifies areas for simplification and innovation as well as new and emerging enabling technologies.
• Represent CDM in global regulatory audits and inspections and ensure successful outcomes in line with business expectations.
• Establishes, fosters and enhances relationships within and across the global organization as well as with service providers.
• Act as deputy for the Head, Clinical Data Management as needed.
• Other responsibilities as assigned.

Education, Behavioural Competencies and Skills

• Bachelor’s/MS Degree or international equivalent preferred, or equivalent combination of education, training and experience
• Degree with a minimum of 15 plus years of experience or equivalency of 20 plus years experience in lieu of degree
• 7+ years of line management experience with prior second-level management experience required.
• Successful experience managing operational vendor relationships and alliance partnerships at a program or portfolio level.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• Requires advanced experience working on Phase I-IV studies across multiple therapeutic areas and programs, and be capable of leading DM activities to support regulatory submissions and inspections.
• 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 perform in a highly dynamic environment.
• Exceptional interpersonal skills, outstanding negotiation and problem solving skills.
• Focused and versatile leader who excels under pressure, ambiguity, frequent change, or unpredictability.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.