Senior Director, Clinical Trial Configuration

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:

• Responsible for effective leadership, strategic planning, and oversight for an organization that supports the configuration and maintenance of technologies supported by Clinical Data Operations & Standards and are utilized in support for clinical trials. 
• Sets the vision, direction, and strategy for area(s) of responsibility and actively contributes to and aligns with the overall 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. 
• Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
• Ensures that technologies used in clinical trial(s) (e.g., EDCs, eCOA, eConsent, Telehealth, IRT, devices, EDCs and RBQM Data Enablement & Analytics) at Takeda are implemented in a compliant manner.  
• Is an accomplished people and relationship manager, establishing and maintaining productive partnerships within Clinical Data Operations & Standards, functional leaders across R&D, and third party service providers. 
• Lead and organize the Clinical Data Configuration technology systems strategy, in collaboration with preferred vendors, therapeutic area units and IT, to support the timely and efficient delivery of global development programs with high quality and within allocated budget.

ACCOUNTABILITIES:

• Lead a group supporting the clinical trial configuration activities including EDC database builders, RBQM Data Enablement & Analytics, 3rd party data (e.g., IRT, DCT, external data) who configure tools that serve different business needs, including but not limited to: Database build & integration in support of Takeda clinical trials, configure tool for RBQM to perform risk review, develop standardization (e.g., EDC library, DTA/DTS templates, RBQM configurations) and innovative use of latest data tools and technologies.

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

• Drives 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 Configuration organization to enable technology strategies that support clinical programs.

• Represent Clinical Trial Configuration as needed during audits and regulatory inspections.

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

• Ensures the Clinical Trial Configuration 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.

• Collaborates 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.

• Provides 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 configuration activities are in compliance with regulatory and company requirement.

• 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:

• Bachelor’s Degree or international equivalent preferred, or equivalent combination of education, training and experience
• 12 or more years of experience in drug development required.
• 8 or more years of project management and leadership experience required.
• 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: electronic Clinical Outcome Assessment (eCOA), electronic Patient Reported Outcome (ePRO), Interactive Voice/Web Response System (IRT), Electronic Data Capture (EDC), RBQM.
• 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-termincentives. 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.