Executive Consultant – Vice President, Quantitative Clinical Pharmacology

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🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

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👔 Vice-président

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Clinical Outcomes Solutions

Site WebLinkedInTous les Emplois

51 - 200 employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions est un cabinet de conseil mondial en résultats cliniques qui offre un soutien et des services complets dans tous les aspects de la recherche sur l'évaluation des résultats cliniques (COA). L'entreprise aide à informer les soins aux patients en capturant la voix des patients grâce à des méthodes scientifiques innovantes. Elle guide les organisations dans la navigation des complexités de la recherche sur les résultats cliniques en élaborant des stratégies et des solutions pour capturer des données précises. Fiable pour les entreprises pharmaceutiques et biotechnologiques, la société garantit la conformité réglementaire et l'optimisation des résultats pour les patients.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

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