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United States
Remote only
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Senior Manager R&D Quality Analytics & Portfolio Insights is a specialized R&D Quality role focused on applying advanced analytics, statistical methods, and technology-enabled approaches to strengthen independent Quality oversight of clinical development, participant protection, patient safety, and regulated research activities. This position requires practical expertise in clinical and patient-safety Quality and uses data as a means to identify emerging risks, generate actionable quality insights, and support timely, evidence-based decisions by accountable GCP, GVP, GLP, and GCLP Quality Leads.
The role develops, implements, and maintains fit-for-purpose analytical methods and independent oversight-support tools tailored to regulated R&D activities. These may include statistical monitoring, predictive risk models, anomaly-detection methods, patient-safety and adverse-event reporting analytics, data-informed audit packages, risk indicators, dashboards, automated monitoring, natural-language tools, and other scalable capabilities that support Quality by Design, Risk-Based Quality Management, audit and inspection readiness, vendor, process, and system oversight, and targeted risk mitigation.
The position integrates and interprets complex clinical, safety, laboratory, monitoring, operational, and quality data to identify study-, site-, subject-, vendor-, process-, product-, and portfolio-level signals that may affect participant protection, patient safety, data integrity, scientific reliability, or regulatory compliance. The role translates these signals into clear insights and recommendations for R&D Quality colleagues and cross-functional partners.
Essential Functions of the Job:
R&D Quality Oversight and Risk Analytics
Partner with R&D Quality leadership and GCP, GVP, GLP, and GCLP stakeholders to identify priority quality questions, emerging risks, oversight gaps, and opportunities for proactive intervention.
Apply quality, regulatory, scientific, and operational context to ensure analytical methods remain relevant to participant protection, patient safety, data integrity, scientific validity, and the reliability of regulated R&D activities.
Conduct cross-study, cross-program, cross-vendor, and cross-process analyses to identify recurring, systemic, or portfolio-level risks that may not be visible through individual study or functional review.
Develop and maintain meaningful key quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio surveillance methods aligned with RBQM and Quality by Design principles.
Clinical, Safety, and Research Analytics
Analytical Product Development and Maintenance
Translate R&D Quality and business needs into clear analytical objectives, data requirements, functional specifications, acceptance criteria, implementation plans, and measurable outcomes.
Design, develop, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools using SQL, R, Python, Power BI, and other approved technologies.
Use automation, machine learning, natural-language processing, generative AI, or other emerging methods where they provide a justified, fit-for-purpose improvement
Data Quality, Assurance, and Lifecycle Governance
Perform data profiling, mapping, cleaning, transformation, source-to-report reconciliation, and root-cause analysis to confirm the accuracy, completeness, consistency, timeliness, and reliability of analytical outputs.
Ensure analytical and AI-enabled solutions are appropriately governed through documented intended use, data lineage, testing, validation or assurance, access controls, version control, change management, human review, explainability, performance monitoring, and retirement planning proportionate to risk.
Maintain appropriate technical and quality documentation to support reproducibility, traceability, inspection readiness, and continued fitness for purpose in a regulated R&D environment.
Partnership, Communication, and Capability Building
Create executive-ready visualizations, quality narratives, risk summaries, and recommendations that explain what the data means, why it matters, and what action should be considered.
Support Quality Management Review, portfolio quality surveillance, RBQM governance, audit planning, inspection readiness, vendor oversight, computerized-system oversight, and continuous improvement through timely and relevant analytical insights.
Partner with Clinical Operations, Clinical Development, Data Management, Biometrics, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, laboratory functions, RBQM, Audit and Inspection Management, Global Technology Solutions, data engineering, and enterprise platform teams.
Lead or coordinate analytics workstreams from problem framing and data assessment through development, testing, implementation, adoption, monitoring, and benefit realization.
Stay current with global R&D regulatory expectations, industry practices, statistical methods, responsible AI principles, and emerging technologies relevant to GCP, GVP, GLP, and GCLP Quality oversight.
Additional Qualifications:
Experience in pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life-sciences environment, with demonstrated knowledge of R&D Quality, clinical quality, quality assurance, compliance, risk management, or regulated research and development operations.
Strong working knowledge of GCP and ICH requirements, with familiarity or experience in GVP, GLP, GCLP, data integrity, computerized-system assurance, and global R&D Quality expectations.
Experience with structured and unstructured data, data mapping, data cleaning, reconciliation, transformation, data modeling, automated quality checks, and data pipelines.
Experience applying statistical analysis, central statistical monitoring, anomaly detection, forecasting, predictive modeling, machine learning, natural-language processing, generative AI, or related methods to practical clinical, safety, research, or quality problems.
Ability to understand complex R&D Quality and operational processes and translate them into scalable technical solutions without losing regulatory context, scientific relevance, or business usability.
Ability to communicate technical findings clearly to nontechnical stakeholders and convert complex analyses into concise, actionable quality recommendations.
Other duties as assigned.
Supervisory Responsibilities:
No direct people-management responsibility is required at this time. The position may provide technical leadership, coaching, and work direction to analysts, contractors, interns, external vendors, and cross-functional project teams.
Computer Skills:
Advanced proficiency with SQL and hands-on proficiency with R or Python.
Experience with Power BI or comparable visualization and business-intelligence platforms.
Experience with statistical programming, central monitoring, anomaly detection, predictive modeling, or machine-learning tools and methods.
Experience with APIs, data warehouses, cloud platforms, ETL/ELT workflows, Git or comparable version-control tools, and analytical development environments.
Experience with automation, natural-language processing, generative AI, or model deployment and monitoring tools is preferred.
Proficiency with Microsoft Office applications; experience with clinical, safety, laboratory, RBQM, audit, and quality platforms is preferred.
Other Qualifications:
Communication & Interpersonal Skills
Excellent written, verbal, presentation, and interpersonal communication skills.
Ability to collaborate effectively across global, cross-functional, clinical, safety, research, quality, data, and technical teams.
Ability to work with sensitive or confidential clinical, safety, quality, laboratory, and patient-level information in accordance with applicable requirements.
Significant Contacts
R&D Quality Leadership and all R&D Quality functions
GCP, GVP, GLP, and GCLP Quality teams
Audit Management and Inspection Management
Risk-Based Quality Management, Clinical Operations, Clinical Development, Data Management, Biometrics, and Medical Monitoring
Pharmacovigilance, Regulatory
Interacts with all levels of BeOne
Travel: May require up to 20% travel
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.