VP, Global Clinical Development

🕒 Agosto 28

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

👻 Score fantasma 13%

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BioCryst Pharmaceuticals, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals em 2023-04

Healthcare • Consulting • Logistics

A BioCryst Pharmaceuticals, Inc. é uma empresa global de biotecnologia focada na descoberta, desenvolvimento e comercialização de novos tratamentos orais com pequenas moléculas e proteínas para doenças raras, notadamente o angioedema hereditário (AEH). Fundada em 1986, a BioCryst utiliza design de medicamentos guiado por estrutura, química medicinal e tecnologias avançadas para desenvolver medicamentos de primeira classe ou superiores, e trabalha em estreita colaboração com pacientes, grupos de apoio e parceiros globais para levar os tratamentos ao mercado.

Descrição

• Provide strategic leadership for personnel management, operations, matrix team integration, and clinical development planning • Ensure efficient and productive clinical development across all stages of drug development • Lead development and implementation of initiatives coordinating the company’s clinical programs • Integrate the strategic clinical plan into research and product development missions • Oversee performance against trial metrics, organizational objectives, and operational strategy • Lead changes in Clinical Development functions to scale and deliver high-quality clinical trials across assets and indications • Set goals and evaluate performance for direct reports and the department • Support career paths, training, and leadership development plans • Manage departmental budgets and resourcing strategy • Build quality-focused clinical infrastructure and implement corrective actions • Develop SOPs aligned with regulatory requirements and ensure consistent implementation and documentation • Ensure inspection readiness of active and completed studies • Set outsourcing strategy and oversee vendors, CROs, and escalation management • Collaborate with stakeholders on trial design, scientific rigor, regulatory pathways, and pipeline advancement • Participate in governance bodies and processes including Portfolio Review Committee, stage gate reviews, and Development Review Group • Develop communications presenting company programs and products to prospective KOLs and investigators • Champion patient-focused clinical development and represent patient advocacy and voice in trial planning, design, and conduct

🎯 Requisitos

• MD with a minimum of 10 years pharmaceutical development experience, preferably gained in a sponsor and/or CRO role • At least 5 years in a senior management role or an equivalent combination of education and experience • Demonstrated drug development experience within the biotech/pharmaceutical industry • Expertise in clinical trial design, conduct, analysis, and interpretation of scientific data • Experience building, training, mentoring, and motivating clinical development teams in industry • Highly developed line management and matrix team skills, including collaboration and influencing across functions at senior level • Ability to multitask across a broad range of activities and maintain strong priorities • Driven to progress programs and timelines at very rapid speeds • Equal employment opportunity compliance and applicable work authorization requirements