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Senior Director, Global Strategic Feasibility, Study Start Up
BeOne Medicines. Oversee strategic planning and feasibility assessments for global clinical studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in global clinical study feasibility assessments, strategic planning, and study start-up documentation. Proven ability to lead cross-functional teams, optimize processes, and utilize data analytics for informed decision-making.
Highest-signal resume keywords
Global Clinical Study FeasibilityStudy Start-Up Documentation ManagementData Analysis and InterpretationLeadership in Cross-Functional TeamsProcess Improvement and Standardization
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Feasibility AssessmentClinical Study ManagementData AnalyticsProcess OptimizationInformed Consent DevelopmentLab Manual CreationInvestigator Brochure DevelopmentTherapeutic Area KnowledgeStrategic ThinkingDecision-Making
Soft Skills
Team LeadershipRelationship ManagementMentoringCollaborationInfluencing
Tools & Technologies
Microsoft Office SuiteCTMS ApplicationsEDC ApplicationsCitelineStudytrove
Industry Keywords
Clinical OperationsGlobal Clinical DevelopmentStudy OptimizationFeasibility MethodologiesRegulatory Affairs
About the role
Key responsibilities & impact- Oversee strategic planning and feasibility assessments for global clinical studies
- Lead the global strategic feasibility team and work with regional strategic feasibility teams
- Lead Study Start-Up documentation specialists to accelerate study-level and asset documentation
- Ensure global and country-level strategic feasibility during study planning
- Drive high-quality study start-up documentation and predictable enrollment forecasts using data analytics and company performance curves
- Establish and improve global strategic feasibility processes, procedures, systems, and study start-up documentation
- Oversee global strategic feasibility proposals aligned with corporate objectives, therapeutic areas, and regional requirements
- Standardize data documentation, data assets, tools, and processes globally
- Drive process optimization initiatives for feasibility methodologies, tools, and metrics
- Collaborate with Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, and other stakeholders
- Establish and maintain partnerships with vendors, investigative sites, and key opinion leaders
- Build, lead, and mentor a high-performing feasibility and study start-up team
- Identify feasibility risks and develop mitigation strategies affecting timelines, budget, and study success
- Present feasibility process and tool development progress, metrics, and recommendations to senior management and stakeholders
- Represent Global Clinical Operations and Global Strategic Feasibility in global projects supporting BeOne R&D goals
- Provide line management and drive ownership and accountability within the team and with external stakeholders
Requirements
What you’ll need- Bachelor’s degree or higher in a scientific, medical or healthcare discipline
- BA or BS with 12+ years of experience in Feasibility, Clinical Study Management, Personnel Management and Operations Management, or an MA/MS with 8+ years of experience
- Prior experience in a leadership capacity is essential
- Experience with study optimization vendors, tools, and methods
- Experience managing processes and timelines associated with Study Start-Up documentation, including Informed Consent development, Lab Manual creation, and Investigator Brochures
- Demonstrated process improvement experience, including mapping processes, measuring components, and delivering standardization and efficiency
- Proven experience in data analysis and data interpretation to inform decision-making
- Expertise in country/site identification, feasibility, and study startup strategies
- Experience managing, influencing, building, and managing relationships and achieving results with senior partners in an environment with competing priorities
- Strong understanding of clinical study operations, feasibility assessment, and global clinical development processes
- Knowledge of multiple therapeutic areas is highly desirable
- Proven ability to lead and inspire teams, including cross-functional teams in a matrix environment
- Demonstrated strategic thinking and informed decision-making based on feasibility assessments and business objectives
- Microsoft Office Suite, CTMS applications, EDC applications, analytic tools such as Citeline and Studytrove, and additional feasibility software
- Travel as needed
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness