At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
As the Director of Clinical Quality Analytics in Performance Analytics & Reporting in Business Insights & Analytics, you define, oversee and implement the analytic strategy for measuring the quality & compliance of trial operations for BMS's innovative pipeline. You partner with clinical compliance, quality & risk management, and process owners to ensure effective measures and analytics are in place and leveraged to enable a data driven approach to trial quality management.
You create and execute the clinical quality analytics plan, both near and long term. You know how to analyze data to derive meaningful insights for leaders. You actively share objective performance and analytic results at relevant quality council forums and quality reviews. You will be a trusted partner enabling data driven decision for clinical compliance and GCP quality. If you are passionate about the intersection of metric & data analytics and effective operations & compliance, we look forward to meeting you!
Key Responsibilities and Major Duties
- Lead data analytics for GCP quality to ensure a data driven approach is consistently applied to monitoring quality and compliance of business processes supporting trial operations
- Develop and implement analytic strategy & roadmap to optimally enable clinical quality and compliance and risk assessments
- Drive insights, with a focus on quality metrics at global and regional levels, evaluating performance relative to industry peers and thresholds for action
- Actively participate in quality management initiatives, councils or reviews to deliver data driven insights and share key quality indicators that will predict risk or potential outcomes
- Translate leadership needs into actionable analytic plans
- Enable monthly, quarterly analytic reviews and deliver high-value analyses of trial quality according to needs of strategic and operational leaders
- Direct the appropriate and timely development of predictive models of GCP quality, compliance and risk given needs of team leads in associated areas and data maturity
- Proactively network and liaise with cross functional business stakeholders to identify, contextualize and deliver high value analytics and insights, while ensuring objectivity and consistency across the enterprise
- Direct delivery of diagnostic and descriptive analytics to identify performance trends, root cause assessments and identify areas of continuous improvement
- Direct development & enhancement of quality monitoring analysis tools, ensuring they meet key stakeholder needs
- Coordinate annual clinical quality benchmarking programs
- University graduate. Advanced degree preferred.
- 10+ years' experience in the pharmaceutical or related industry
- Demonstrated ability to build relationships with executives and peers, including ability to manage stakeholder engagement
- Experience in clinical operations or quality-related functions, or analytical functions is preferred
- Understanding of regulatory requirements & guidelines (ICH, GCP) and Corrective and Preventative Actions (CAPA) is ideal
- Excellence in translating stakeholder needs into testable hypotheses that will drive an insight or action to add value to a business process
- Demonstrated ability to use data to drive decisions and answer key business questions
- Demonstrated ability to draw insights from data
- Deep knowledge on how to effectively measure processes with data
- Understanding of the application of advanced analytics, including predictive analytic modeling approaches related to structured and unstructured data is ideal
- Experience delivering in a matrix organization, including articulating value propositions, balancing trade-offs and managing demand
- Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment
- Develops strong collaborative working relationships with key stakeholders
- Ability to manage competing priorities
- Proven accountability, and demonstrated excellent interpersonal, communication, and problem-solving capabilities
- Analytical mind-set to develop effective business solutions and connect analogous concepts across domains
- Familiarity and experience with systems used to manage clinical trials and trial quality; e.g., clinical trial management systems (Oracle, Rave), EDC, site monitoring, document management, QMS, QET
- Excel (advanced proficiency)
- Microsoft Office
- Data analysis tools is a plus (SAS, R, data mining, visualization tools/techniques, SQL, etc)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.