Executive Consultant - Vice President, Quantitative Clinical Pharmacology
- 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.
- 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.
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