Director, Global Clinical Process Management

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $143.3k - $193.3k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 1%

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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 Global Clinical Operations • Promote efficient, consistent, sustainable, and compliant processes and standards across Global Clinical Operations • Serve as the primary GCOE point of contact for one or more GCO processes, including SOPs, Work Instructions, and related standards • Develop content and collaborate with Global Process Owners and Subject Matter Experts on GCO procedural documents • Act as Global Process Owner when appropriate • Lead process management initiatives, controlled-document revisions, continuous improvement, change management, and implementation activities • Identify and advance innovative ideas that improve GCO processes • Lead document review and approval workflows • Advise on processes owned by other functions that impact GCO processes and standards • Establish partnerships with GCO and cross-functional groups, including GCP Compliance and Learning and Development • Contribute to the strategic direction of training materials related to GCO processes • Ensure alignment with ICH-GCP and applicable regulatory requirements

🎯 Requirements

• Bachelor’s degree required; master’s degree or other relevant post graduate qualification preferred • Fluent English (oral and written) • 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 • Efficient in Microsoft Excel, Outlook, Word, PowerPoint, and Project • 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 skills • Strong presentation skills

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for 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