Executive Consultant – Vice President, Quantitative Clinical Pharmacology

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🕒 Março 20

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Vice-presidente

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Clinical Outcomes Solutions

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Clinical Outcomes Solutions é uma consultoria global de desfechos clínicos que oferece suporte e serviços abrangentes em todos os aspectos da pesquisa de Avaliação de Desfecho Clínico (COA). A empresa ajuda a informar o cuidado ao paciente capturando a voz do paciente por meio de métodos científicos inovadores. Ela orienta as organizações a navegar nas complexidades da pesquisa de desfechos clínicos, elaborando estratégias e soluções para capturar dados precisos. Confiada por empresas farmacêuticas e biotecnológicas, a empresa garante conformidade regulatória e otimização dos resultados dos pacientes.

Descrição

• Serve as an externally recognized expert in Quantitative Clinical Pharmacology, Pop-PK/PK-PD modeling, MIDD, and quantitative regulatory strategies. • Lead the development and dissemination of innovative methodologies, contributing to Cytel’s scientific leadership through publications, conference presentations, and webinars. • Provide high-level strategic guidance to clients on clinical development plans, regulatory and market access pathways, trial design optimization, and quantitative decision-making. • Act as the primary point of contact for major Strategic Consulting accounts, ensuring delivery excellence and long-term partnership development. • Identify and pursue new business opportunities across Cytel’s consulting and analytics offerings, shaping solutions that meet revenue, profitability, and client satisfaction objectives. • Build and maintain relationships with senior stakeholders, including regulatory agencies (e.g., FDA, EMA), key opinion leaders, and executive-level client personnel. • Oversee and contribute to Pop-PK and PK/PD modeling, non-compartmental analysis (NCA), and broader QPP analytical activities. • Provide mentorship, technical oversight, and direction to consultants and analysts, building a high-performing quantitative team. • Support non-QPP engagements when needed, such as statistical design, adaptive/Bayesian methodologies, simulation-based planning, or data science initiatives.

🎯 Requisitos

• Minimum 5+ years of hands-on QPP experience; 15+ years overall experience in consulting, clinical development, or health research preferred for VP-level responsibilities. • Demonstrated leadership in MIDD, Pop-PK/PK-PD modeling, and quantitative strategy within drug development. • Experience interacting with regulatory authorities and contributing to regulatory submissions is highly desirable. • Proven expertise in Pop-PK/PK-PD modeling, NCA, and interpretation of quantitative pharmacology results for CSR and reporting. • Proficiency in Phoenix WinNonlin/NLME, R, and strong understanding of computational and statistical methods used in clinical development. • Excellent technical writing, oral communication, and presentation skills; ability to clearly communicate complex quantitative concepts. • Strong organizational, analytical, and problem-solving abilities; able to operate effectively in a fast-paced, high-growth environment.

🏖️ Benefícios

• Health insurance • Retirement plans • Paid time off • Professional development opportunities