Develop and implement clinical pharmacology and pharmacometrics strategies across all stages of clinical development including pediatric development programs.
Manage the design, development, and application of NCA, population PK, exposure–response, PK/PD, and PBPK models to inform decision-making across programs.
Oversee modeling and simulation-based analyses to support dose selection and study design for clinical trials in pediatric populations, and support global regulatory submissions and labeling.
Author and contribute to clinical pharmacology sections of regulatory documents (e.g., IB, DSUR, briefing books, NDA/MAA submissions) and support interactions with global regulatory agencies.
Design clinical pharmacology studies and manage study execution and CROs/vendors. Conduct PK data analyses, provide study-level oversight, including authoring, review, and approval of protocols, analysis plans, and reports.
Present results to internal teams and external stakeholders, including contributions to scientific publications, abstracts, and conference presentations.