General Description: - As the regional strategic feasibility lead 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.
Key Responsibilities:Data-Driven Strategic Feasibility:- Accountable for the development and implementation of the regional feasibility strategy
- Collaborate with the global strategic feasibility lead, study teams, and cross-functional stakeholders in the region to deliver strategic feasibility assessments based on comprehensive data analysis.
- Provide crucial insights to inform decision-making for effective protocol design and execution.
- Conduct and ensure the delivery of high-quality feasibility/site identification assessments. This includes conducting feasibility outreach and participating in intelligence gathering and risk assessment to coordinate feasibility projects and deliverables.
- Evaluate regional capabilities to conduct protocols and achieve targeted enrollment goals, aiming to strive operational excellence.
- Act as a liaison between the global strategic feasibility team and region/country
Support for Regional Study Teams:- Assist regional study teams in the successful delivery of allocated feasibility studies.
- Ensure adherence to timelines, quality standards, and BeOne's expectations for all studies in scope.
- Coordinate regional Site and Patient engagement activities for TA/Indication/program and Trial in scope.
Expertise Development:- Build expertise within the region regarding Standard of Care, disease landscape, and competitive intelligence.
- Stay informed about competing trials, recent or upcoming approvals, prescribing data, insurance claims, and recruitment capabilities.
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 BeOne R&D goals.
Supervisory Responsibilities: - Drive high level of ownership and accountability within team and with external stakeholders
- Provide mentoring and training to junior members in the team
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 environments.
- Shown experience or willingness to learn how to develop 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/ Experience Required: - Bachelor's degree (or equivalent) 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.
Salary Range: $143,300.00 - $193,300.00 annually
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.
