Vice President, Quantitative Clinical Pharmacology

Job not on LinkedIn

🔥 12 hours ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

👔 Vice President

🦅 H1B Visa Sponsor

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👻 Ghost score 25%

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 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 through publications, conference presentations, and webinars • Provide strategic guidance to clients on clinical development plans, regulatory and market access pathways, trial design optimization, and quantitative decision-making • Act as primary point of contact for major Strategic Consulting accounts • Identify and pursue new business opportunities across consulting and analytics offerings • Build and maintain relationships with regulatory agencies, key opinion leaders, and executive-level client personnel • Oversee and contribute to Pop-PK and PK/PD modeling, non-compartmental analysis, and broader QPP analytical activities • Mentor and provide technical oversight to consultants and analysts • Support statistical design, adaptive/Bayesian methodologies, simulation-based planning, and data science engagements when needed • Collaborate with business developers, statisticians, software teams, and data scientists • Represent QPP expertise within multidisciplinary engagements • Travel as required to engage with clients and internal stakeholders

🎯 Requirements

• 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 and R • 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 • Ability to operate effectively in a fast-paced, high-growth environment