Director, Global Clinical Operations, Compliance

🔥 15 hours ago

🇦🇷 Argentina – Remote

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

👻 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

• Build, collaborate and manage key relationships to support compliance-related business needs within Global Clinical Operations • Provide quality guidance, direction and expertise for compliant conduct of study programs • Design, implement and monitor measures to reduce compliance risks and enhance clinical trial conduct • Develop partnerships with enterprise business partners and stakeholders to advance compliance solutions and embed preventive compliance • Lead or participate in global and cross-functional initiatives, working groups and project teams • Ensure compliance with ICH GCP, applicable laws and regulations, and the BeiGene Quality Management System • Lead root cause assessments, corrective and preventive actions, and lessons-learned activities for quality issues, site non-compliance, audits and inspections • Identify and escalate significant compliance issues, including serious breaches • Contribute to risk identification and management strategies for clinical studies and regulated drug development activities • Provide consultative guidance on systems, processes, procedures, regulations and tools used in clinical studies • Maintain expertise in global GCP guidance, regulations, industry best practices and internal policies • Support quality issue trending, analysis and review; lead corrective and preventive actions • Provide actionable quality and compliance data and insights to GCO leadership • Report the organization's compliance state with critical GCOE functions • Research evolving laws and regulations and recommend responses based on industry benchmarks and best practices • Lead inspection preparation and management for local-country and global Health Authority inspections • Provide leadership, oversight, guidance and subject matter expertise to assigned project teams • Oversee direct/indirect reports and support their mentoring, coaching and professional development • Conduct staff meetings and provide performance-review and career-development feedback • Manage assigned project/activity budgets and maintain awareness of the GCO Compliance project portfolio

🎯 Requirements

• Fluent English is required • Preferred experience in the pharmaceutical/biotech industry • Bachelor’s degree in Life Sciences, Medicine, Quality Management or related field and at least 10 years of relevant experience; or Master’s degree in these fields and at least 7 years of relevant experience • Relevant experience in drug development, clinical operations, clinical quality assurance, medical affairs, clinical regulatory compliance or a related field • Impeccable ethics, sound judgment and discretion • Experience planning, prioritizing and managing high-level initiatives and projects • Knowledge of stakeholder management and influencing change • Knowledge of ICH GCP, applicable laws, regulations and industry standards • Understanding of corporate and organizational policies, procedures and guidelines • Strong organizational, planning, prioritization, verbal and written communication skills • Ability to synthesize complex or voluminous content into clear, concise and actionable communications • Ability to analyze and simplify complex systems or processes into pragmatic solutions • Ability to assess GCP compliance risks and articulate potential business impact • Ability to influence and lead with and without authority in a matrix organization • Proficiency with Word, Excel, PowerPoint, Visio and Outlook • May manage direct/indirect reports as needed

🏖️ Benefits

• May be required to travel 10–20% • Equal opportunity employment