Associate Director, Global Study Management Lead

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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

• Manage Global Study Management Associates (gSMAs) across one or multiple regions, including line management, mentorship, coaching, and career development • Assign qualified gSMA resources to studies aligned with deliverables and portfolio goals • Oversee gSMA training compliance • Review data metrics, CTMS, eTMF, and other reports to identify risks and improvement opportunities • Ensure gSMA task delivery meets inspection-readiness quality, timeline, and standards requirements • Escalate and resolve issues for assigned studies • Drive best practices and process improvements supporting studies and teams • Lead PSM team process-optimization and end-to-end improvement initiatives with cross-functional stakeholders • Collaborate with internal and external regional and global stakeholders • Support teams in solving complex problems and shape the gSMA development strategy • Forecast demand, balance workloads, and optimize gSMA resourcing across studies • Lead interviews, selection, and hiring of gSMA staff • Facilitate team onboarding and study handovers • Ensure timely resource assignment and adequate planning for global clinical-study delivery • Establish priorities and structures for study objectives and manage overlapping priorities • Implement change-management frameworks and ensure consistent adoption of processes, systems, and standards • Monitor compliance with ICH Guidelines, Good Clinical Practices, regulatory requirements, SOPs, and work instructions • Capture and leverage lessons learned through knowledge management • Build high-performing teams through recruitment, development, and promotion • Conduct performance appraisals and implement performance-management processes for direct reports • Mentor junior team members and oversee development plans • Contribute to training programs, innovative initiatives, and broader strategic initiatives

🎯 Requirements

• Bachelor’s or higher degree in a scientific or healthcare discipline • Life science background preferred, including medicine, nursing, biology, or laboratory technology • 8+ years of experience in the clinical trial industry • Minimum 2 years of line management experience • Solid leadership and management experience as a direct line manager or cross-functional team lead • Proficiency in Microsoft Office Suite, including Excel, PowerPoint, and Project • Fluent written and verbal English • Knowledge of ICH Guidelines, Good Clinical Practices, regulatory agency requirements, SOPs, and work instructions • Willingness to travel as required by business needs • Exceptions may be made for candidates with relevant clinical operations experience

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards opportunity • Employee Stock Purchase Plan participation • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Reasonable accommodation in the application process