"Alerted.org

General Description:

As the Regional Strategic Feasibility Lead Senior Manager within Global Clinical Operations (GCO), you will play a vital role in collaboration with the global strategic feasibility lead, study teams, and cross-functional stakeholders in the region to deliver data-driven strategic feasibility reports for early to late-stage medicines development. Your responsibilities will encompass site identification and recruitment and retention recommendations, ensuring the successful execution of clinical trials from concept to completion.

Essential Functions of the job:

**Strategic Liaison and Cross-functional Coordination** :

+ Act as the primary point of contact for the Global Strategic Feasibility and Regional Clinical Operations teams for Feasibility and Re-Feasibility activities.

+ Liaise cross-functionally to expedite and predictively deliver feasibility insights at various levels (TA, indication, program, study), ensuring standardization of data, tools, and processes for quality decision-making.

Data-driven Feasibility Recommendations:

+ Combine and integrate data from internal stakeholders and external sources to provide clear feasibility strategies for site identification, recruitment, and retention at the TA/indication/program level.

+ Utilize comprehensive data analysis, including local treatment standard of care, disease prevalence, drug landscape, and historical trial data, to inform protocol development and establish geographic footprints and proposed sites for participation in clinical studies.

+ Consider the unique needs of each indication, patient population, study, and business priorities.

Enrollment Forecasting and Risk Mitigation:

+ Utilize competitive intelligence data to develop accurate study startup forecasts, benchmark assumptions, and enrollment plans.

+ Maintain patient enrollment forecasts strategically, adjusting for new influencing factors and developing risk mitigation plans.

+ Lead the design and implementation of study-specific recruitment programs, collaborating with study teams, vendors, and CROs as needed to optimize participant recruitment.

Continuous Improvement and Innovation:

+ Implement creative processes, methodologies, data, and technologies to enhance the delivery of Feasibility and Study Startup Services.

+ Contribute to ongoing strategic planning, capability assessments, and training efforts to ensure successful feasibility support.

+ Stay up to date with current therapeutic area knowledge, assessing its impact on operational strategies.

+ Perform root cause analysis and develop mitigation strategies to address study execution and enrollment challenges.

+ Participate in regional and global projects, representing Clinical Operations and Study Optimization to support BeiGene R&D goals.

Supervisory Responsibilities:

+ Drive high level of ownership and accountability within team and with external stakeholders

+ Line Manage - Country Feasibility and Clinical Trial Diversity teams

**Computer Skills:** Microsoft Office Suite, CTMS applications, EDC applications, analytic tools (e.g. Citeline, Trialtrove, etc.) and additional feasibility software

Other Qualifications:

+ Experience with trial optimization vendors, tools, and methods.

+ Proficiency with software models and database structures.

+ Expertise in principles driving country/site identification, feasibility, and study 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 study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives.

+ Clinical trial patient and investigator recruitment experience

+ Validated experience in project and budget management.

+ Confirmed experience working with Global teams.

**Travel:** Travel might be required as per business need.

Education Required:

Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline with minimum of 12 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management and Operations Management.

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.