Director, Global Clinical Process Management Lead

This is a fully remote position, open to applicants in Australia.

📋 Description

• Lead and facilitate global clinical process management activities within Global Clinical Operations.

• Promote processes and standards that are efficient, consistent, sustainable, and compliant across GCO.

• Support innovative concepts that enhance processes and ensure alignment and follow-through from idea to execution.

• Ensure compliance with ICH-GCP and relevant regulatory requirements.

• Act as the primary point of contact for one or more GCO processes, including SOPs, Work Instructions, and associated standards.

• Develop content and collaborate with Global Process Owners and Subject Matter Experts on the technical writing of SOPs, Work Instructions, templates, and tools.

• Lead process management initiatives with GCPC, which includes the revision or creation of controlled documents, continuous improvement, change management, and implementation.

• Identify, assess, align stakeholders around, and promote innovative process enhancements.

• Oversee document review and approval workflows.

• Provide guidance on and review processes managed by other functions that affect GCO processes and standards.

• Establish and nurture partnerships with GCO and cross-functional teams, including GCP Compliance and Learning and Development.

• Contribute to the creation and strategic direction of training materials related to GCO processes.

• Provide matrix supervision.

⛳️ Requirements

• A Bachelor’s degree is required; a Master’s or other relevant postgraduate qualification is preferred.

• A relevant Bachelor’s degree is a minimum requirement, preferably in a science or healthcare discipline.

• Typically, 12 or more years of progressive experience in the pharmaceutical, biotechnology, or clinical research sectors.

• Experience in leading complex global or regional clinical operations programs, process portfolios, or enterprise-wide improvement initiatives within a matrix organization.

• Expert knowledge of clinical operations processes, ICH-GCP, clinical trial regulations, inspection readiness, and compliance expectations.

• Proven experience in translating regulatory requirements into actionable global standards.

• Expertise in end-to-end process design, governance, harmonization, optimization, implementation, adoption, and lifecycle management.

• Experience serving as a Global Process Owner, senior process lead, or trusted advisor to senior stakeholders.

• Strong change management skills, including stakeholder engagement, communication, training strategy, implementation planning, and sustainment.

• Exceptional influencing, facilitation, negotiation, and problem-solving abilities.

• Strong analytical skills and risk-based decision-making capabilities.

• Experience utilizing data and performance metrics to assess process effectiveness and drive improvements.

• Excellent written and verbal communication skills, with the ability to present complex topics clearly to both technical and executive audiences.

• Demonstrated commitment to quality, operational excellence, collaboration, and continuous improvement.

• Willingness to travel as needed.

🏝️ Benefits

• Competitive market compensation package that includes a performance-based annual bonus scheme.

• Company shares with a generous welcome grant!

• Opportunities for in-house and external learning and development.

• Comprehensive benefits program.

• A dynamic, collaborative, supportive, inclusive, and enjoyable team environment.