Role Summary
Senior Director, Head of Feasibility, Americas. BeOne seeks a highly motivated, collaborative leader to deliver data-driven feasibility reports for early to late-stage medicines development, overseeing site identification and recruitment/retention recommendations to support clinical trial execution.
Responsibilities
- Act as the primary point of contact for Global Strategic Feasibility and Regional Clinical Operations teams for Feasibility and Re-Feasibility activities.
- Liaise cross-functionally to deliver feasibility insights at various levels (TA, indication, program, study), ensuring standardization of data, tools, and processes for quality decision-making.
- Combine and integrate data from internal and external sources to provide clear feasibility strategies for site identification, recruitment, and retention at the TA/indication/program level.
- Utilize data analysis to inform protocol development and establish geographic footprints and proposed sites for participation in studies.
- Consider the unique needs of each indication, patient population, study, and business priorities.
- Develop accurate study startup forecasts, benchmark assumptions, and enrollment plans using competitive intelligence data.
- Maintain patient enrollment forecasts and develop risk mitigation plans; design and implement study-specific recruitment programs in collaboration with study teams, vendors, and CROs.
- Implement processes, methodologies, data, and technologies to enhance feasibility and study startup services; contribute to strategic planning and training.
- Stay current with therapeutic area knowledge and assess its impact on operational strategies; perform root cause analysis and mitigation strategies for study execution and enrollment challenges.
- Participate in regional/global projects representing Clinical Operations and Study Optimization to support R&D goals.
- Lead and nurture ownership and accountability within the team and with external stakeholders; line manage Country Feasibility and Clinical Trial Diversity teams.
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 and data interpretation to drive informed decision making.
- Experience managing and influencing senior partners in conflicting priority environments.
- Ability to develop study delivery strategies and tactical/operational plans aligned to commercial and regulatory objectives.
- Clinical trial patient and investigator recruitment experience; project and budget management experience.
- Experience working with Global teams.
- Travel may be required as per business need.
Education
- Bachelorβs degree (or equivalent) or higher in a scientific, medical, or healthcare discipline with a minimum of 12 years of combined experience in Feasibility, Clinical Trial Management, Personnel Management, and Operations Management.
Skills
- Strategic liaison and cross-functional coordination
- Data-driven feasibility planning and site identification
- Enrollment forecasting and risk mitigation
- Continuous improvement and innovation in feasibility and study startup services
- Strong analytical thinking and data analysis
- Effective communication with clarity and stakeholder management
Additional Requirements
- Experience with Global teams and leading regional feasibility initiatives.