Director, Global Clinical Process 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

• Lead and support global clinical process management activities within GCO • Ensure processes, standards, and procedural documents are efficient, consistent, sustainable, and compliant with regulatory requirements • Serve as the primary GCOE point of contact for assigned GCO processes, SOPs, work instructions, and standards • Develop GCO procedural content with Global Process Owners and Subject Matter Experts • Lead process management initiatives, controlled-document revisions, continuous improvement, change management, and implementation • Lead document review and approval workflows • Advise and review processes owned by other functions that impact GCO processes and standards • Build partnerships with GCO teams and cross-functional stakeholders • Contribute to process-related training strategy and materials • Liaise between GCO Regional Heads, regional organizations, and the GCPM team • Translate process changes into practical implications for regional and local teams • Consolidate regional feedback and promote alignment on process adoption • Escalate regional concerns and recommendations to the Head of GCPM and relevant GCPM Process Lead • Assess potential impacts of local and regional regulatory or operational changes on global processes • Mentor selected Associate Directors within GCPM

🎯 Requirements

• Fluent English (oral and written) • Relevant bachelor’s degree required; science/healthcare discipline preferred • Minimum of 8 years of experience in the pharmaceutical and/or biotechnology sector • Extensive knowledge of clinical operations processes, ICH-GCP, and compliance management • Knowledge of clinical trial regulations • Experience in clinical trial process design, harmonization/optimization, and implementation • Experience working in a matrix environment and in global teams • Excellent interpersonal, problem-solving, negotiation, and conflict-resolution skills • Excellent organizational skills and predisposition to quality management and process improvement • Effective oral and written communication • Strong presentation skills

🏖️ 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