Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.
Clinical Quality Management (CQM) at Takeda
Clinical Quality Management is responsible for implementing an enterprise-wide strategy for Risk Based Quality Management (RBQM) and Adaptive Monitoring (AM) to focus on critical-to-quality risks that drive data quality and site performance across the entire study lifecycle.
As the Associate Director, RBQM Enablement, you will be responsible for all aspects of Takeda's Risk Based Quality Management (RBQM) platforms including but not limited to technical configuration, conduct analyses using Central Statistical Monitoring (CSM), develop and maintain KRI & QTL library, maintain user access, troubleshooting, system integrations, and ongoing feature improvement to leverage a data-driven approach for managing risk across study teams and related functional areas.
Support development of advanced analytics for RBQM activities, including Quality Tolerance Limit (QTL) analysis and Key Risk Indicators (KRI) to support identification of important study issues which require monitoring, management, and adaptation of study plans
Map, manage, and design RBQM dataflows to integrate with other relevant clinical and operational databases at study, program, and enterprise level
Develop specifications and perform technical configuration of RBQM solution based on Study Risk Assessment (SRA)
Perform analyses in CSM Platform, interpret anomalies, and assist with explanation of complex findings
Summarize findings and communicate (written report or oral) results to stakeholders
Accountable for RBQM platform administration and user access management
Support and participate in developing and improving training materials for RBQM solutions
Provide internal and external training on RBQM solutions, as required
Develop and maintain library of QTLs and KRIs for studies across TAUs
Write signals based on critical data and critical processes as defined in the SRA
Assist RBQM Operations and study team with the investigation and explanation of complex CSM signals and outputs
Identify, assess, and roll-out vendor technology enablement for CSM in collaboration with the RBQM Strategy & Insights
Ensure that appropriate documentation is produced and maintained in the Trial Master File
Serve as technology Subject Matter Expert (SME) for RBQM platform and clinical data flow
Collaborate with R&D IT to troubleshoot technical issues related to RBQM solutions
Participate in the development, evaluation, and continuous improvement of RBQM and Adaptive Monitoring solutions
Assist CQM leadership in responding to technology questions, requests, and audits
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education: Bachelor's Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
Minimum of 8 years of experience in the pharmaceutical or CRO industry
Minimum of 5 years of experience in clinical data management and/or SAS programming supporting statistical analyses
Minimum of 3 years of managerial and supervisory experience
Experience with all phases of development in one or more therapeutic areas preferred
Advanced knowledge of broad drug development process and expertise in the cross-functional interfaces for the adoption of Risk Based Quality Management
Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, and WHODRUG
Robust understanding of the drug development process and clinical trial execution
Knowledge of RBQM IT systems
Experience with implementing RBQM Central Statistical Monitoring solutions
Strong technical understanding of statistical analyses, and the use of SAS programming language in the processing of clinical data, including data transformations, derivations, formatting, and reporting
Strong technical understanding of how data flows across RBQM applications and the rest of Takeda's R&D IT portfolio, including clinical and operational databases at study, program, and enterprise level
Demonstrated aptitude for data analytics and understanding of statistical concepts
Strong track record of building solid partnerships and cross-functional collaborations
Supports a culture of continual improvement and innovation; promotes knowledge sharing
Ability to influence without authority
Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo
Base Salary Range: $180-200K, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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