Senior Director, Global Strategic Feasibility, Study Start Up

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $206.2k - $276.2k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Oversee strategic planning and feasibility assessments for global clinical studies • Lead the global strategic feasibility team and work with regional strategic feasibility teams • Lead Study Start-Up documentation specialists to accelerate study-level and asset documentation • Ensure global and country-level strategic feasibility during study planning • Drive high-quality study start-up documentation and predictable enrollment forecasts using data analytics and company performance curves • Establish and improve global strategic feasibility processes, procedures, systems, and study start-up documentation • Oversee global strategic feasibility proposals aligned with corporate objectives, therapeutic areas, and regional requirements • Standardize data documentation, data assets, tools, and processes globally • Drive process optimization initiatives for feasibility methodologies, tools, and metrics • Collaborate with Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, and other stakeholders • Establish and maintain partnerships with vendors, investigative sites, and key opinion leaders • Build, lead, and mentor a high-performing feasibility and study start-up team • Identify feasibility risks and develop mitigation strategies affecting timelines, budget, and study success • Present feasibility process and tool development progress, metrics, and recommendations to senior management and stakeholders • Represent Global Clinical Operations and Global Strategic Feasibility in global projects supporting BeOne R&D goals • Provide line management and drive ownership and accountability within the team and with external stakeholders

🎯 Requirements

• Bachelor’s degree or higher in a scientific, medical or healthcare discipline • 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 • Experience with study optimization vendors, tools, and methods • Experience managing processes and timelines associated with Study Start-Up documentation, including Informed Consent development, Lab Manual creation, and Investigator Brochures • Demonstrated process improvement experience, including mapping processes, measuring components, and delivering standardization and efficiency • Proven experience in data analysis and data interpretation to inform decision-making • Expertise in country/site identification, feasibility, and study startup strategies • Experience 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, including cross-functional teams in a matrix environment • Demonstrated strategic thinking and informed decision-making based on feasibility assessments and business objectives • Microsoft Office Suite, CTMS applications, EDC applications, analytic tools such as Citeline and Studytrove, and additional feasibility software • Travel as needed

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness