Senior Director, Regional Clinical Study Management

🔥 15 hours ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Provide inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers • Lead assigned clinical study portfolios and designated therapeutic areas or assets • Deliver regional studies or portfolios with inspection readiness, within agreed timelines and budget • Act as regional lead for studies across indications or programs • Lead regional clinical operations teams and serve as escalation point for regional issues • Align regional resources and deliverables with portfolio goals • Develop regional tools, work instructions, and SOPs • Lead regional clinical operations strategy and decision-making • Collaborate with regional stakeholders and provide portfolio progress updates to senior management and Global Clinical Study Managers • Lead cross-departmental teams and develop cross-functional strategies • Oversee clinical study planning and management from feasibility through closeout • Optimize trial feasibility, country allocation, and site selection • Coach and mentor regional study managers and CRAs • Provide regional input on clinical supplies, drug inventories, labels, regulatory approvals, and comparator reimbursement • Drive regional data collection, data entry, and query resolution • Oversee Clinical Study Report planning and execution as required • Ensure compliance with protocols, SOPs, ICH/GCP, and applicable regulations • Maintain inspection readiness throughout the study lifecycle • Manage regional vendor needs, investigator fees, site payments, patient travel reimbursement, resources, headcount, and budgets • Interview, line manage, and evaluate regional clinical study managers • Conduct performance appraisals and support professional development plans

🎯 Requirements

• Bachelor's degree in a scientific or healthcare discipline and 12+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry • Alternatively, preferably a master's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry • Proven experience in clinical research • Relevant experience as team lead in clinical functions • Experience across multiple studies preferred • Proficiency with MS Office and project planning applications • Ability to travel as required by business need

🏖️ Benefits

• Equal opportunity employer • Travel may be required as per business need