Consultant – Pharmacology

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🕒 vor 14 Tagen

🇺🇸 Vereinigte Staaten – Remote

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Clinical Outcomes Solutions

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions ist eine globale klinische Beratungsgesellschaft, die umfassende Unterstützung und Dienstleistungen in allen Aspekten der Bewertung klinischer Ergebnisse (Clinical Outcome Assessment, COA) bietet. Das Unternehmen trägt zur Verbesserung der Patientenversorgung bei, indem es die Stimme des Patienten durch innovative wissenschaftliche Methoden erfasst. Es leitet Organisationen durch die Komplexität der Forschung zu klinischen Ergebnissen, indem es Strategien und Lösungen entwickelt, um präzise Daten zu erfassen. Pharma- und Biotechnologieunternehmen vertrauen der Firma, um die Einhaltung der Vorschriften und optimierte Patientenergebnisse zu gewährleisten.

Beschreibung

• 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. • Work closely with Cytel’s business developers, statisticians, software teams, and data scientists to deliver integrated, high-value solutions. • Represent QPP expertise within multidisciplinary engagements, ensuring strategic alignment and scientific rigor. • Travel as required to engage with clients and internal stakeholders.

🎯 Anforderungen

• 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.