Director, Clinical Trial Reporting

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Set the vision, direction, and strategy for area(s) of responsibility and actively contribute to and align with the overall Global Development Office (GDO) strategies and operating models. 

• Responsible for the effective leadership, strategic planning, and oversight for Clinical Trial Reporting (CTR) organization. Ensure on time, high quality, and within budget delivery for all assigned CTR activities globally within a key asset, franchise/portfolio and/or therapeutic area(s).

• Provide CTR expertise and leadership in support of global development programs as well as post-marketing registration and non-registration studies.

• Drive strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.

• Ensure that technologies used in clinical trial(s) (e.g., Jreview, Veeva CDM, R, RShiny) at Takeda are implemented in a compliant manner.  

• Responsible for oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.

• Accomplished people and relationship manager, establishing and maintaining productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers.

• Champion CDOS operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CTR capabilities.

• Responsible for direct line management of employees.

• Partner 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. 

• Lead and organize Trial Reporting activities for assigned clinical studies and non-clinical data cleaning activities.

• Developing parameterized data cleaning reports to support data review plan.

ACCOUNTABILITIES:

• Lead a group supporting the clinical trial reporting activities who develop reporting and analytics that serve different business needs, including but not limited to: Cross Functional Data Review Artifacts, develop standardization and innovative use of latest data tools and technologies

• Foster and ensure close collaboration with SET members (Data Engineer, Data Configuration engineer, Clinical, Clinical Data Managers, Statistical Programmers, Statisticians and other stakeholders) in the clinical data lifecycle

• Drive strategy with preferred vendors to ensure compliance to standards for all development programs and marketed products to ensure regulatory submission compliance.

• Manage team of employees and contractors to assist clinical trial configuration team to maintain compliance

• Manage clinical trial reporting organization to enable technology strategies that support clinical program activities (e.g., Cross Function Data Review and Cleaning).

• Represent Clinical trial reporting as needed during audits and regulatory inspections

• Provide oversight to Global Development Operations technology vendors on delivery of accurate and efficient solutions to support therapeutic area management of global development programs.

• Ensure the Clinical trial reporting vendor’s technology processes meet or exceed the regulatory requirements to support Takeda’s global development projects, marketed products, Vaccine Business unit.

• Partnership with the Takeda business system owner for technologies maintained by Takeda in Global Development Operations.  Collaborates with IT to ensures compliance with required maintenance responsibilities.

• Responsible for planning and management of budgets related to data technology licensing, hosting and deliverables. 

• Collaborate with Quality Assurance to contribute to the Takeda strategy for audits and assessments of vendor clinical trial configuration systems for compliance with regulatory requirements and principles of the software development life cycle.

• Provide support of regulatory inspection in collaboration with Quality Assurance and GCP & Operational Excellence organizations.

• Accountable for the review, development, maintenance and optimization of processes to ensure that clinical trial reporting activities are in compliance with regulatory and company requirements

• Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners.

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EDUCATION AND EXPERIENCE:

• BS/BA required, or MS preferred in a health-related, life science area or technology-related fields.

• 10 or more years drug development experience; 7 or more years of project management and leadership experience.

• Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus.

• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.

• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.

• Health care business acumen with a comprehensive understanding of the pharmaceutical industry Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

• Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles.

• Solid experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies due to evolving GXP regulations.

• Demonstrated Business Relations Management experience with multiple vendors, setting strategy and implementation for multiple clinical technologies: (e.g., Jreview, SAS, R, RShiny, Elluminate, Veeva CDB, CluePoint).

• Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy.

• Experience with budget planning and vendor management.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, 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, and well-being benefits, among others. 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.