[Hiring] Senior Director, Global Strategic Feasibility and Study Start Up @BeiGene

Role 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 teams, and collaborates closely with cross-functional stakeholders while leading a team of Study Start Up documentation specialists.

• Oversees 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.
• Drives process optimization initiatives to enhance feasibility assessment methodologies, tools, and metrics, ensuring efficiency, quality, and scalability.
• Collaborates with internal stakeholders, including Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, and Biostatistics, to ensure alignment and provide strategic input for study design and execution.
• Establishes and maintains effective partnerships with external organizations, including vendors, investigative sites, and key opinion leaders, to enhance study feasibility and optimize resources.
• Builds, leads, and mentors a high-performing team of feasibility and study start-up professionals, fostering a collaborative and innovative work environment.
• Identifies potential risks and challenges in study feasibility and develops mitigation strategies to minimize their impact on timelines, budget, and study success.
• Prepares and presents 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.
• Line management of global strategic feasibility team members, driving a high level of ownership and accountability within the 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 and data interpretation to drive informed 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.
• Strong understanding of clinical study operations, feasibility assessment, and global clinical development processes. Knowledge of multiple therapeutic areas is highly desirable.
• 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.
• 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.

Requirements

• Travel: As needed.
• 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.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• 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.

Company Description

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.