Cytel
Executive Consultant – Vice President, Quantitative Clinical Pharmacology
Cytel, Cambridge, Massachusetts, us, 02140
We are seeking an Executive Consultant – Vice President of Quantitative Clinical Pharmacology to join our Strategic Consulting team. This role blends scientific leadership, strategic advisory, client relationship development, and technical excellence in population modeling and quantitative clinical pharmacology. The successful candidate will leverage both deep quantitative expertise and strong business acumen to expand Cytel’s thought leadership, drive complex consulting engagements, and guide clients in shaping optimal regulatory and clinical development pathways.
Strategic Consulting & Thought Leadership
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.
Client Engagement & Business Development
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.
Scientific & Analytical Leadership
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.
Cross-Functional Collaboration
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.
Experience
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.
Required Technical & Professional Skills
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.
Cytel Inc. is an Equal Employment / Affimative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
#J-18808-Ljbffr
Strategic Consulting & Thought Leadership
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.
Client Engagement & Business Development
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.
Scientific & Analytical Leadership
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.
Cross-Functional Collaboration
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.
Experience
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.
Required Technical & Professional Skills
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.
Cytel Inc. is an Equal Employment / Affimative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
#J-18808-Ljbffr