Director, Global Clinical Process Management Lead

🔥 5 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 11%

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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 GCO • Support innovative ideas that strengthen processes and ensure alignment and follow-through from concept through implementation • Ensure alignment with ICH-GCP and applicable regulatory requirements • Serve as 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 technical writing of SOPs, Work Instructions, templates, and tools • Lead process management initiatives with GCPC, including controlled-document revision or creation, continuous improvement, change management, and implementation • Identify, evaluate, align stakeholders around, and advance innovative process improvements • Lead document review and approval workflows • Advise on and review processes owned by other functions that impact GCO processes and standards • Establish and maintain partnerships with GCO and cross-functional groups, including GCP Compliance and Learning and Development • Contribute to the development and strategic direction of training materials related to GCO processes • Provide matrix supervision

🎯 Requirements

• Bachelor’s degree required; Master’s or other relevant post graduate qualification preferred • Relevant Bachelor’s degree minimum, preferably in a science/healthcare discipline • Typically 12 or more years of progressive experience in the pharmaceutical, biotechnology, or clinical research sector • Experience leading complex global or regional clinical operations programs, process portfolios, or enterprise-wide improvement initiatives in a matrix organization • Expert knowledge of clinical operations processes, ICH-GCP, clinical trial regulations, inspection readiness, and compliance expectations • Experience translating regulatory requirements into practical global standards • Experience in end-to-end process design, governance, harmonization, optimization, implementation, adoption, and lifecycle management • Experience operating as a Global Process Owner, senior process lead, or trusted advisor to senior stakeholders • Strong change management capability, including stakeholder engagement, communication, training strategy, implementation planning, and sustainment • Excellent influencing, facilitation, negotiation, and problem-solving skills • Strong analytical and risk-based decision-making skills • Experience using data and performance measures to evaluate process effectiveness and drive improvement • Excellent written and verbal communication skills, with ability to present complex topics clearly to technical and executive audiences • Demonstrated commitment to quality, operational excellence, collaboration, and continuous improvement • Ability to travel according to requirements

🏖️ Benefits

• Market competitive compensation package including performance-based annual bonus scheme • Company shares (generous welcome grant!) • In-house and external learning and development opportunities • Fantastic benefits program • Dynamic, collaborative, supportive, inclusive, and fun team environment