Director, RBQM Central Statistical Monitoring (CSM)

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Job Summary:

This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements to achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and reporting under RBQM Central Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during RBQM Risk Assessment.

Responsibilities:

CSM Execution:

• Provides tactical approaches and leads implementation of vision for risk-based quality management within impacted Daiichi Sankyo functions globally and with external parties as required.

• Champions ‘Quality by Design’ and Quality Risk Management approaches to quality management within Daiichi Sankyo RD and works to develop a culture that supports these approaches.

• Create and implement processes for Daiichi Sankyo RBQM future state including operating model, SOPs, study resource requirements, and supportive technology (as needed), for the risk-based central monitoring function.

• Interacts with and influences internal management and study level stakeholders on risk-based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.

• Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a precursor to the risk-based central monitoring during study conduct.

• Monitors external environment and incorporates RBQM industry benchmarking, best practices, and emerging solutions within Daiichi Sankyo.

• Ensures DS and any RBQM vendors meets risk-based quality management expectations as defined by ICH, FDA, EMA, PMDA and other Health Authorities.

• Oversee Development and Implementation of RBQM Standards, Tools and Training

• Ensure Daiichi Sankyo RBQM study level practices for RD studies comply with industry regulations / updates (e.g. new requirements), including conduct of impact assessments and implementation of changes as required.

• Lead development and maintenance of RBQM standards such as guiding principles, risk, quality tolerance limit (QTL) libraries, and critical-to-quality factors.

• Lead RBQM Center of Excellence for central statistical monitoring topics, ensure optimal utilization of the cross functional SMEs to embed RBQM across portfolio of studies and ensure adoption.

• Engage with selection of RBQM vendors or RBQM platforms and tools

• Develop and implement tools to maximize the consistency, effectiveness, and efficiency of the RBQM processes across Daiichi Sankyo compounds with a focus on oversight, lessons learned and inspection readiness.

• Lead assessment of training needs and ensure delivery of RBQM CSM Training with Learning and Development team members.

• Lead development and implementation of process improvement initiatives related to RBQM CSM to improve quality and ensure patient safety and data quality and integrity.

• Establish, measure, analyze and report on RBQM CSM related metrics and present outputs to Leadership and Management to drive RBQM Implementation.

• Oversee RBQM central statistical monitoring activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee and mentor junior staff to ensure proper implementation and execution of RBQM and inspection readiness.

• Review and determine acceptability of CRO / vendor RBQM practices and associated tools with outsourcing, following Daiichi Sankyo standards. Support internalization of RBQM and Central Statistical Monitoring activities including inter