Senior Director, Global Strategic Feasibility and Study Start Up

General Description:

The Head of Global Strategic Feasibility and Study Start-Up at BeOne is a senior leadership role responsible for overseeing the strategic planning and feasibility assessments for global clinical studies. This individual leads the global strategic feasibility team, works with regional strategic feasibility team, and collaborates closely with cross functional stakeholders while leading a team of Study Start Up documentation specialists to accelerate key study level/asset documentation while driving quality and consistency. This individual is accountable to ensure global and country level strategic feasibility during the study planning stage to support the study execution with high quality study start-up documentation and predictable enrollment forecasts based upon key data analytics and company performance curves. The Head of Global Strategic Feasibility and Study Start-Up plays a crucial role in shaping the company's global clinical study strategy and decision-making process while directly impacting study-start up timelines. This individual is accountable to establish and improve the global strategic feasibility processes, procedures, and systems and study start-up documentation to strive for continuous optimization.

Essential Functions of the Job:

• Strategic Planning: overseeing the global strategic feasibility proposals for global clinical studies in alignment with corporate objectives, therapeutic areas, and regional requirements.

• Ensures standardization in data documentation, data assets, tools and processes globally to advise quality decision making at TA, indication, program and study levels

• Continuous Improvement: Drive process optimization initiatives to enhance feasibility assessment methodologies, tools, and metrics, ensuring efficiency, quality, and scalability.

• Stakeholder Collaboration: Collaborate with internal stakeholders, including Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, and Biostatistics etc. to ensure alignment and provide strategic input for study design and execution.

• External Partnerships: Establish and maintain effective partnerships with external organizations, including vendors, investigative sites, and key opinion leaders, to enhance study feasibility and optimize resources.

• Team Leadership: Build, lead, and mentor a high-performing team of feasibility and study start-up professionals, fostering a collaborative and innovative work environment.

• Risk Management: Identify potential risks and challenges in study feasibility and develop mitigation strategies to minimize their impact on timelines, budget, and study success.

• Reporting and Communication: Prepare and present feasibility process and tool development progress, metrics, and recommendations to senior management and key stakeholders, fostering transparency and informed decision-making.

• Participates in global projects representing Global Clinical Operations and Global Strategic Feasibility team to support BeOne R&D goals.

• Supervisory Responsibilities: Line management of global strategic feasibility team members. Drives high level of ownership and accountability within team and with external stakeholders

Qualifications

• Experience with study optimization vendors, tools, and methods.

• Experience managing process and timelines associated with Study Start-Up documentation including Informed Consent development, Lab Manual creation, Investigator Brochures, etc.

• Demonstrated process improvement experience to map processes, measure components and deliver standardization and efficiency.

• Proven experience in data analysis, data interpretation to drive inform decision making

• Expertise in principles driving country/site identification, feasibility, and study startup strategies.

• Demonstrated experience in managing, influencing, building, and managing relationships and achieving results with senior partners in an environment with competing priorities.

• Clinical Development Expertise: Strong understanding of clinical study operations, feasibility assessment, and global clinical development processes. Knowledge of multiple therapeutic areas is highly desirable.

• Leadership Skills: Proven ability to lead and inspire teams, fostering a collaborative and results-oriented culture. Experience managing cross-functional teams and working in a matrix environment.

• Strategic Thinking: Demonstrated ability to think strategically and make informed decisions based on comprehensive feasibility assessments and business objectives.

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

Other Qualifications:

Travel: As needed

Education Required:

Bachelor’s degree or higher in a scientific, medical or healthcare discipline; An advanced degree (e.g., MSc, PhD, MBA) is preferred. 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.

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.