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Precision for Medicine is seeking a Director of Site Start-up to lead the Site Start-up (SSU) department across European operations. This role provides strategic leadership and operational oversight of the SSU function, which manages critical clinical trial initiation activities including Informed Consent Form review, regulatory document collection, IRB/Ethics Committee submissions, and site contract negotiations.
You will work closely with the Head of Site Start-up to develop and implement the SSU framework, establish best practices, and drive continuous improvement across the department. Key responsibilities include:
• Leading and managing the SSU team (SSU Leads, Specialists, and Site Contract Management staff) to deliver projects on time, within budget, and to quality standards
• Overseeing site start-up delivery across multiple regulatory jurisdictions (local and regional), ensuring compliance with ICH Guidelines, Good Clinical Practices, and company SOPs
• Collaborating with Clinical Operations, Project Management, and cross-functional teams to plan and execute SSU activities globally and regionally
• Managing escalations and implementing timely remediation of SSU concerns
• Optimizing processes and delivery to enhance profitability and meet budget targets
• Supporting team career development, succession planning, and compliance with company policies
• Partnering with Business Development on opportunity development, proposals, and bid defense
• Developing, measuring, and reporting SSU KPIs to drive continuous improvement
• Acting as a change management ambassador for organizational growth and expansion
The ideal candidate will have extensive experience in clinical operations, site management, or regulatory affairs within the clinical research or pharmaceutical industry, with demonstrated leadership capability managing cross-functional teams and complex, multi-stakeholder projects.
