Senior Principal Pharmacometrician

Role Summary

Senior Principal Pharmacometrician. Lead discussion and implementation of pharmacometrics methodologies and provide pharmacometrics support for regulatory submissions and integrated evidence generation contributing to drug development decisions with internal and external partners.

Responsibilities

• Provide global strategic pharmacometrics leadership and support to clinical development programs of low to mid complexity, based on relevant technical and disease area knowledge
• Contextualizing the modeling question with the relevance to drug and disease biology
• Developing an understanding of drug development applied to scoping relevant questions for Pharmacometrics analysis
• Communication of modeling to project teams in multiple settings such as decision board meetings, small sub-teams, etc.
• Drive the pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions) with oversights
• Assess pharmacometrics requirements insuring the integration of pharmacometrics information into transition of drug development milestones / decision boards
• Contribute to Integrated Evidence generation by leveraging disease progression and Pharmacokinetic-Pharmacodynamic modeling techniques using varied data sources, including Real World Data
• Align with the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) on the pharmacometrics strategy, execution, and delivery of assigned projects

Qualifications

• Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent) with 3+ years‚Äô experience in clinical drug development applying model-based methods using NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
• Diverse experience in pharma industry on incorporation of model-informed drug development (MIDD) strategies into drug development plans across all phases and answering challenging questions on dose and regimen justification, study design, safety analysis among others
• Ability to develop and deliver clear, concise presentations, drive discussions and decision making for both internal and external meetings

Skills

• Pharmacometric modeling and regulatory submission support
• Dose-exposure-response analysis, population PK/PD, disease progression modeling, clinical trial simulation
• Communication of complex modeling to diverse audiences

Education

• Ph.D. in relevant field or equivalent