Director, Site Start-up

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🌐 Royaume-Uni, Espagne, +5 autres pays – Distant

🇬🇧 Royaume-Uni – Télétravail 🇪🇸 Espagne – Télétravail 🇵🇱 Pologne – Télétravail 🇭🇺 Hongrie – Télétravail 🇷🇸 Serbie – Télétravail 🇸🇰 Slovaquie – Télétravail 🇷🇴 Roumanie – Télétravail

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Precision For Medicine

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €75 000 000 Private Equity Round en 2015-12

Healthcare • Consulting • Logistics

Precision for Medicine est un leader spécialisé dans l’accompagnement du développement et de la mise sur le marché de thérapies innovantes, notamment en oncologie, dans les maladies rares et les maladies auto-immunes. Grâce à une gamme complète de services — gestion d’essais cliniques, services de laboratoire et collecte de biospécimens — l’entreprise intègre des capacités avancées en biomarqueurs ainsi que des solutions de fabrication pour fluidifier des processus de développement clinique complexes. Sa mission est d’accélérer la recherche et d’apporter aux patients des solutions médicales qui changent la vie, en dépassant les inefficacités traditionnelles souvent observées dans le paysage du développement pharmaceutique.

Description

• Provide SSU team guidance, leadership, and overall support for project delivery, communication, human resources, revenue enhancement, procedures, systems, and processes • Support overall management of site start-up delivery through direct management and/or cross-functional oversight of IRB/EC submissions, Competent Authorities submissions, governing organizations, site contracts, budget negotiations, and other start-up requirements • Establish the PFM SSU framework with the Head of Site Start Up, including SSU intelligence, tools, methodology, risk evaluations, and mitigations • Support collaboration with Clinical Operations, project management, and other cross-functional departments in planning, execution, and governance of SSU activities • Support corporate and departmental business strategies • Act as an ambassador for change management as PFM’s global structure evolves • Provide leadership and oversight on SSU programs, including large and increasingly complex programs • Manage escalations and remediation of SSU concerns • Optimize processes and delivery to meet or exceed budget targets • Partner with Global Resourcing to assess and manage SSU team members and ensure cost, time, and quality goals • Support SSU 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 • Work with global and regional functional leaders to support SSU project strategy and delivery • Support SSU evaluations and implement required project changes • Develop, measure, and report SSU KPIs and lead continuous improvement • Uphold PFM values, quality commitments, policies, procedures, regulatory guidelines, and customer service standards • Use communication skills and experience to reinforce culture, motivate the SSU team, maintain engagement, and drive retention

🎯 Exigences

• Bachelor’s degree in life sciences or related field, or equivalent combination of education, training, and experience • Minimum 12 years of experience in clinical research, including extensive Site Start-up experience • Experience working for a Clinical Research Organisation (CRO) • Experience in people management • 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