- Serves as the primary point of contact for the global strategic feasibility team and liaises cross-functionally to enable global strategic feasibility proposal delivery
- Ensures standardization in use of data, tools and process across regions to advise quality decision making at TA, indication, program levels
- Partners with internal stakeholders including global clinical program leaders, global clinical study managers, development core team etc.; combines and integrates data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution.
- Partners with global clinical program leaders and development core team on study design optimization
- Serves as the subject matter expert in feasibility tools, technologies, databases and platforms
- Support modelling of strategy options for relevant internal and external data assets, predictive models
- Support interpretation of data and development of recommendations on operational strategy
- Provide data-driven operational feasibility strategy, including country selection, patient and site allocation, site identification, and recruitment and retention recommendations at TA/indication/program level taking into consideration outstanding needs of indication, patient population, study, and business priorities
- Contributes in efforts to implement creative processes, methodologies, data, and technologies to ensure ongoing delivery of valued global strategic feasibility service.
- Leads and contributes to Strategic planning meetings, training calls, kick off meetings and ongoing team meetings to ensure alignment of strategies and ongoing feasibility support.
- Supports the Head of Global Strategic Feasibility to develop global processes and procedures and coordinates with regions to ensure standardization and consistency
- Supports global strategic feasibility related initiatives and taskforces for continuous improvement and optimization
- Collaborates with Applied Innovations, Data Science & Operational Excellence, Clinical Systems & Innovation in the development of feasibility tools, systems and platforms
- Determines risk/mitigation planning to feasibility or recruitment and retention of the participants.
- Maintains current therapeutic area knowledge and assesses impact of evolving information on operational strategies.
- Exhibits the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to execution and patient enrollment and retention.
- Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeiGene R&D goals.
- Experience with trial optimization vendors, tools, and methods.
- Proven experience in data analysis, data interpretation to drive inform decision making
- Proficiency with software models and database structures.
- Expertise in principles driving country/site identification, feasibility, and startup strategies.
- Validated experience in data analysis, data interpretation to drive inform decision making
- Tried experience in managing, influencing, building, and managing relationships and achieving results with senior partners in conflicting priority environment
- Shown experience or willingness to learn how developing delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives
- Clinical trial patient and investigator recruitment and retention experience
- Validated experience in project and budget management
- Confirmed global working experience
- Oversee training and development of feasibility team members
- Drives high level of ownership and accountability within team and with external stakeholders
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Associate Director, Global Strategic Feasibility - Saint Paul, United States - BeiGene
Description
General Description:
The Global Strategic Feasibility leads the development of global strategic feasibility proposals together with the regional strategic feasibility teams.
Close partnership with global program & management team for design and delivery of early to late-stage medicines development across global clinical operations (GCO).
Good understanding of global, regional, and country landscape and regulatory requirements.Drive high-quality strategic feasibility/site identification assessments based on Standard of Care, disease landscape and competitive intelligence including but not limited to competing trials, recent or upcoming approvals, prescribing data, insurance claims data, diversity, and recruitment capabilities.
This includes intelligence gathering and risk assessment with therapeutic knowledge balanced with data analytics and interpretation.
The Global Strategic Feasibility supports the Head of Global Strategic Feasibility to establish and improve the global strategic feasibility processes, procedures, and systems to strive for continuous optimization.
Essential Functions of the job:
Computer Skills: Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Trialtrove, etc.) and additional feasibility software
Other Qualifications:
Supervisory Responsibilities:
Education Required:
Bachelor's degree or higher in a scientific, medical or healthcare discipline with minimum of 8+ years of combined experience in Feasibility, Clinical Trial Management, Personnel Management and Operations Management.
Travel: as needed
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
