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 Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide leadership and overall support to the Site Start-up team across project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes • Support management of site start-up delivery, including IRB/Ethics Committee submissions, Competent Authority submissions, site contracts, budget negotiations, and other start-up requirements • Establish the Precision for Medicine Site Start-up framework, including intelligence, tools, methodology, risk evaluations, and mitigations • Collaborate with Clinical Operations, project management, and other cross-functional departments on global and regional Site Start-up planning, execution, and governance • Support corporate and departmental business strategies and change management for organizational growth and expansion • Provide leadership and oversight on complex Site Start-up programs • Manage escalations and remediation of Site Start-up concerns • Optimize processes and delivery to support profitability and budget targets • Partner with Global Resourcing to assess and manage Site Start-up leads, specialists, and site contract management staff • Support team career development, growth, succession planning, and compliance with company policies and regulatory guidelines • Coordinate Site Start-up Lead participation in client meetings and presentations • Collaborate with Business Development on opportunity development, proposals, budgeting, bid defense preparation, and attendance • Support Site Start-up project strategy and delivery with global and regional functional leaders • Evaluate Site Start-up activities and implement required project changes • Develop, measure, and report Site Start-up KPIs and lead continuous improvement • Reinforce company culture and values, motivate the team, maintain engagement, and drive retention

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or equivalent combination of education, training, and experience • Minimum of 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 to interface effectively in a team setting • Excellent organizational skills, attention to detail, and customer service demeanor • Proven experience in strategic planning, risk management, and change management • Fluency in English