Risk Management Lead
vor 3 Wochen
BeiGene is seeking an experienced Associate Director to lead our Risk Based Quality Management (RBQM) program. As a key member of our clinical development team, you will be responsible for creating risk assessments, following up on quality signals, and contributing to the advancement of our RBQM program.
Key Responsibilities:- Provide onboarding training and tools to assigned teams to aid in the adoption of RBQM.
- Facilitate risk management with stakeholders to identify critical to quality factors and risks.
- Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, and others to analyze risks and issues using quality performance data.
- Draft, maintain, and archive documentation of risk management activities.
- Trend risks and issues across related entities.
- Support the study team in optimizing controls applied based on risk evaluation.
- Develop and lead culture change and communication activities with stakeholders.
- Conduct ad hoc risk assessments as needed to support clinical development.
- Bachelor's degree in Business or Science-related field, Master's degree preferred.
- 5-10 years of experience leading risk assessments in the pharmaceutical industry or equivalent.
- Prior experience deploying RBQM programs across clinical development preferred.
- Ability to work independently to complete management and oversight activities.
- Experience working and communicating within cross-functional teams.
- Critical thinking and analytical skills to understand and analyze complex data.
- Therapeutic area specific experience and knowledge - Oncology/Hematology preferred.
- Ability to use relevant technology and risk-based tools/platforms effectively.
- Proven track record in delivering agreed results against a plan and timeline.
- Understanding of ICH and regulatory environment.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeiGene is an equal opportunities employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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