Director Clinical Operations

Location: UK / EU / US – Remote

Reports To: VP, Clinical Operations

Role Overview: APX Life Sciences is partnering exclusively with a well-funded, stealth-mode biotechnology company developing a highly innovative therapeutic platform with the potential to transform patient care. This newly created Director / Senior Director, Clinical Operations position offers a rare opportunity to play a foundational role in shaping clinical operations within an emerging biotech. You will provide strategic and operational leadership across pivotal global clinical trials while helping establish scalable processes, systems, and best practices as the organisation grows. This is a highly visible, hands-on leadership role requiring close collaboration with executive leadership, cross-functional teams, CROs, and external partners to deliver high-quality studies with speed, agility, and scientific excellence.

Key Responsibilities:

• Clinical Study Leadership: Lead the operational delivery of global clinical studies from start-up through close-out, ensuring execution aligns with the overall clinical development strategy. Partner closely with the VP of Clinical Operations on strategic and operational decisions, providing recommendations, identifying key risks, and implementing effective mitigation plans. Thrive in a dynamic, evolving environment where priorities may shift as new scientific and clinical data emerge.
• CRO and Vendor Oversight: Build and lead high-performing partnerships with CROs and external vendors, ensuring delivery against timelines, quality standards, and budget. Drive accountability through proactive oversight, governance, and performance management.
• Clinical Documentation: Review and contribute to key clinical documents including protocols, informed consent forms (ICFs), investigator brochures (IBs), clinical study reports (CSRs), and other essential study documentation.
• Compliance and Inspection Readiness: Ensure all clinical trials are conducted in compliance with ICH-GCP, SOPs, and applicable international regulatory requirements. Maintain inspection-ready Trial Master Files (TMFs) and oversee quality throughout study execution.
• Risk and Issue Management: Proactively identify operational risks and implement mitigation strategies to minimise impact on timelines, budget, and study quality. Escalate critical issues appropriately while driving practical, solution-focused outcomes.
• Budget and Resource Management: Manage study budgets, forecasting, and financial tracking throughout the clinical programme. Support efficient resource planning across internal teams and external partners.
• Leadership and Team Development: Mentor and develop Clinical Trial Managers, Clinical Trial Associates, and other junior team members. Foster a collaborative, high-performance culture suited to an innovative, early-stage biotech environment.
• Process Development: Contribute to the development, implementation, and continuous improvement of SOPs, operational processes, and clinical infrastructure to support organisational growth.

Required Qualifications and Experience:

• 15+ years of progressive global clinical operations experience within biotechnology and/or pharmaceutical companies.
• Experience working within early-stage, high-growth or emerging biotech environments, with the ability to balance strategic thinking and hands-on execution.
• Demonstrated success leading complex global clinical trials across multiple regions.
• Strong working knowledge of ICH-GCP, international regulatory requirements, CTMS, eTMF, and clinical quality standards.
• Extensive experience managing CROs and external vendors, including governance, performance oversight, and delivery management.
• Experience across complex therapeutic areas.
• Comfortable working across global time zones within geographically dispersed teams.
• Experience operating with both outsourced and in-house clinical operating models.
• Proven ability to work with ambiguity, adapt quickly to changing priorities, and deliver results in a fast-paced environment.
• Excellent leadership, communication, stakeholder management, and influencing skills.
• Strong organisational skills with exceptional attention to detail and high-quality written and verbal communication.