Director, Pharmacometrics, Clinical Pharmacology
New
Based in United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 6+ years
- Required Skills
- R
Requirements
- PhD or PharmD in Pharmaceutical Sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering, or related field.
- 6+ years of relevant industry experience in pharmacometrics and model-based drug development.
- Strong expertise in NLME methods, population PK/PD modeling, exposure-response analysis, and clinical trial simulation.
- Hands-on experience with tools such as NONMEM and R strongly preferred.
- Solid understanding of clinical pharmacology principles and therapeutic areas relevant to drug development.
- Experience integrating MIDD approaches across all stages of development and regulatory interactions.
- Strong analytical thinking, scientific reasoning, and ability to interpret complex datasets.
- Excellent communication skills with the ability to explain technical concepts to diverse stakeholders.
- Ability to manage multiple priorities in a fast-paced, matrixed environment with strong independence and ownership.
Responsibilities
- Develop and execute end-to-end modeling and simulation strategies across early- and late-stage clinical development programs.
- Serve as the pharmacometrics expert within cross-functional development teams, guiding scientific and strategic decision-making.
- Deliver timely quantitative insights to support critical development milestones and go/no-go decisions.
- Lead PK/PD, population PK, exposure-response, and disease progression modeling activities using state-of-the-art approaches.
- Define pharmacometric strategies for regulatory submissions, including dose justification and trial design support.
- Collaborate on integrating modeling outputs into broader clinical, regulatory, and development plans.
- Guide exploratory and advanced modeling approaches, including QSP and empirical frameworks linking PK, biomarkers, and outcomes.
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