Senior Director, Global Strategic Feasibility, Study Start Up

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise strategic planning and feasibility evaluations for global clinical trials.

• Direct the global strategic feasibility team and collaborate with regional strategic feasibility teams.

• Manage Study Start-Up documentation specialists to expedite study-level and asset documentation.

• Ensure strategic feasibility at both global and country levels during the study planning phase.

• Utilize data analytics and company performance curves to enhance the quality of study start-up documentation and provide accurate enrollment forecasts.

• Develop and refine global strategic feasibility processes, procedures, systems, and study start-up documentation.

• Oversee global strategic feasibility proposals that align with corporate goals, therapeutic areas, and regional needs.

• Standardize global data documentation, data assets, tools, and processes.

• Lead initiatives for process optimization in feasibility methodologies, tools, and metrics.

• Collaborate with Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, and other stakeholders.

• Build and maintain partnerships with vendors, investigative sites, and key opinion leaders.

• Create, lead, and mentor a high-performing feasibility and study start-up team.

• Identify risks associated with feasibility and develop strategies to mitigate impacts on timelines, budgets, and study success.

• Report on the progress, metrics, and recommendations regarding feasibility processes and tool development to senior management and stakeholders.

• Represent Global Clinical Operations and Global Strategic Feasibility in global projects that support BeOne R&D objectives.

• Provide line management while fostering ownership and accountability within the team and with external stakeholders.

⛳️ Requirements

• A Bachelor’s degree or higher in a scientific, medical, or healthcare field.

• A 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.

• Previous leadership experience is essential.

• Familiarity with study optimization vendors, tools, and methodologies.

• Experience in managing processes and timelines related to Study Start-Up documentation, including Informed Consent development, Lab Manual creation, and Investigator Brochures.

• Demonstrated experience in process improvement, including mapping processes, measuring components, and achieving standardization and efficiency.

• Proven skills in data analysis and interpretation to guide decision-making.

• Expertise in country/site identification, feasibility assessments, and study start-up strategies.

• Experience in managing, influencing, and building relationships while achieving results with senior partners in a context of competing priorities.

• Strong knowledge of clinical study operations, feasibility assessments, and global clinical development processes.

• Familiarity with various therapeutic areas is highly desirable.

• Proven capability to lead and motivate teams, including cross-functional teams within a matrix environment.

• Demonstrated strategic thinking and decision-making grounded in feasibility assessments and business objectives.

• Proficiency in Microsoft Office Suite, CTMS applications, EDC applications, analytic tools such as Citeline and Studytrove, and additional feasibility software.

• Willingness to travel as necessary.

🏝️ Benefits

• Eligibility for annual bonus plans for non-commercial roles.

• Eligibility for incentive compensation plans for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life insurance.

• Paid Time Off.

• Wellness programs.