Director, Site Start Up

🔥 0 minutes ago

🌐 Australia, China, +3 more countries – Remote

🇦🇺 Australia – Remote 🇨🇳 China – Remote 🇸🇬 Singapore – Remote 🇰🇷 South Korea – Remote 🇹🇼 Taiwan – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Provide SSU team guidance, leadership, and support for project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes • Support management of site start-up delivery across IRB/Ethics Committee submissions, Competent Authorities submissions, governing bodies, site contracts, budget negotiations, and other start-up requirements • Establish the PFM SSU framework with intelligence, tools, methodology, risk evaluations, and mitigations • Collaborate with Clinical Operations, project management, and cross-functional departments on global and regional SSU planning, execution, and governance • Support corporate and departmental business strategies • Champion change management for the evolution of PFM’s global structure and growth • Provide leadership and oversight for large and increasingly complex SSU programs • Manage SSU escalations and remediation • Optimize processes and delivery to meet or exceed budget targets • Partner with Global Resourcing teams to assess and manage SSU team members and meet cost, time, and quality goals • Support team career development, growth, and succession planning • Coordinate SSU Lead participation in client meetings and presentations • Collaborate with Business Development on opportunity development, proposals, budgeting, bid defense preparation, and attendance • Support SSU project strategy and delivery with global and regional functional leaders • Evaluate SSU operations and implement required project changes • Develop, measure, and report SSU KPIs and lead continuous improvement • Reinforce PFM culture and values to motivate, engage, and retain the SSU team • Ensure clinical trials comply with local and regional regulatory requirements, ICH Guidelines, Good Clinical Practices, and SOPs

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or equivalent combination of education, training, and experience • Minimum 12 years in clinical research, including extensive Site Start-up experience • Extensive leadership experience or proven competencies for the position • Expert knowledge of GCP/ICH guidelines and the clinical development process • Demonstrated leadership track record • Experience working in a team environment with resource management experience • Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint • Clinical software experience, including CTMS, eTMF, and EDC • Excellent communication and interpersonal skills • Excellent organizational skills, attention to detail, and customer service demeanor • Proven experience in strategic planning, risk management, and change management • Fluency in English