Associate Director, GCP Excellence in Clinical Trials

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:

• Implement and drive management of cross-functional study execution teams’ GCP inspection readiness and inspection preparation strategies, including proactive framework to facilitate process adherence, inspection-risk management, TMF oversight and proactive study team preparedness for audits and inspections.
• Partner with R&D Quality to serve the Clinical Sub-Team (CST)/Study Execution Team (SET) for end-to-end clinical trial delivery compliance and an aligned approach to inspection readiness strategy.
• Increase compliance effectiveness by driving implementation of global initiatives.
• Champion change and provide direct operational excellence strategies for clinical trial delivery projects and initiatives.

ACCOUNTABILITIES:

• Lead the development and implementation of GCP Excellence in Clinical Trials strategies to enable clinical trial functional areas and study teams to embed inspection readiness and process adherence into ways of working. 
• Partner with R&D Quality and GCP Compliance Management to develop GCP inspection strategy in support of submission planning and routine inspections.
• Drive strategies to facilitate and prepare Takeda Study Execution Team for GxP audits and inspections.
• Collaborate with study execution team leadership on adherence to clinical trial delivery procedures and development of effective mitigation and escalation strategies for inspection readiness issues or risks, and ensure effective flow of information between internal and external stakeholders.
• Proactively identify and lead assessments for process/therapeutic area/project risks and drive prioritization of quality deliverables for audits and inspections.
• Develop, lead and oversee strategies for GCP quality and inspection plans, collaborating with Global Development Compliance on CAPAs/ECs and with QA to ensure adherence to the plan.
• Oversee global and program aligned GCP Excellence in Clinical Trials support and associated operations ensuring optimal use of resources and cost efficiency.
• Ensure effective approach to actively lead Strategy Team Meetings and Core Team Meetings for assigned Inspection Readiness projects.
• Collaborate across GCP Excellence in Clinical Trials and with GCP Compliance Management to prepare and facilitate internal audits and regulatory inspections with study execution teams and functional leadership including but not limited to study team preparation, facilitating requests, managing responses and CAPA strategies.
• Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation; providing regular status updates to appropriate stakeholders and leadership.
• Monitor and provide visibility into inspection readiness and TMF health for global studies and programs, working in collaboration with GCP Compliance Management and Compliance Monitoring to ensure compliance monitoring signals are actioned with the study execution team.
• Identify and implement areas for process optimization and delivery tools to promote study team preparedness for end-to-end clinical trial delivery compliance.
• Drive strategy and implementation of risk-based TMF oversight strategies for study execution teams.  Monitor compliance of TMF processes and oversight of resources in the execution of inspection readiness plans.
• Serve as subject matter expert, supporting business process ownership for Inspection Readiness and TMF.
• May serve as inspectorate facing TMF subject matter expert for regulatory inspections of Takeda.
• Contributes to and may lead defined GCP Excellence in Clinical Trials initiatives and departmental goals and objectives.
• Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree or international equivalent required; Life Sciences preferred.
• 8 or more years' experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in compliance or clinical study management or equivalent.
• Experience in leading projects and coordinating collaboration with cross-functional teams.
• Strong strategic thinking, planning, execution, and communication skills.
• Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
• Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

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.