Director, GCO Clinical Program Lead

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BeOne Medicines

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

• Lead strategic operational planning and clinical operational performance for designated clinical programs • Serve as a point of escalation for study and compound-related issues • Provide strategic leadership to global Clinical Study Managers • Build, develop, retain, hire, train, mentor, and manage global gCSM teams • Oversee project delivery, goals, budgets, timelines, quality, and operational KPIs • Collaborate with GCPLs, Franchise Heads, governance teams, and cross-functional R&D leaders on program strategy and execution • Represent GCO in program governance and provide clinical operational insight • Lead or participate in KOL engagement activities and act as a function spokesperson when needed • Evaluate strategic feasibility and budget estimates during early planning and strategy changes • Allocate resources and initiate Clinical Study Team formation • Create annual program budgets and resource forecasts and track DCT goals • Create, review, maintain, and provide input on compound-level documents including IB, DSUR, and protocols • Conduct regular program review meetings and ensure studies track approved budgets and timelines • Report study status, goals, and operational KPIs and enforce quality KPIs • Evaluate preferred global vendors and participate in vendor governance meetings • Create and review performance and development plans for direct reports • Provide line management and mentorship to gCSMs • Drive scientific knowledge development and process improvement across Clinical Operations • Apply ICH/GCP and regulatory expertise to clinical trial execution

🎯 Requirements

• Bachelor or higher degree in a scientific or healthcare discipline • 10+ years’ experience in the clinical trial industry • Deep therapeutic-area expertise • Global program management skills and a global perspective • Project management exposure/experience across the entire lifecycle of multi-region/country clinical trials • Experience in a fast-paced global environment • Experience in people management and program management preferred • Knowledge of ICH/GCP Guidelines and applicable regulatory requirements • Proficiency with MS Office • Experience with project planning applications • Experience with Clinical Trial Management Systems (CTMS) • Ability to travel domestically and internationally, up to 20% • Ability to work with colleagues across various time zones

🏖️ Benefits

• Annual bonus plan eligibility for non-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 benefits • Equal opportunity employer • Reasonable accommodation in the job application process

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