Senior Research Investigator, Pharmacometrics

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Model-based integration of data to generate insights, bridge data-gaps,
inform drug development decisions, and support health authority
interactions. Pharmacometrics (PMx) applications including population
pharmacokinetics and exposure-response.

Responsible for the development and implementation of the model-
informed drug development (MIDD) plan for drugs and other therapeutic
agents in clinical development, in partnership with the Clinical
Pharmacology (CP) Lead for the asset.

Model Informed Drug Development (MIDD) has emerged as a powerful complement to conventional drug development whereby PMx models are developed with data from a variety of sources are utilized to inform drug development decisions and regulatory assessments. MBMA approaches provide a complementary quantitative view of the competitor/comparator space. Generally, MIDD informs dose and regimen selection and hypotheses to be investigated in clinical studies; and supports regulatory assessments of the clinical pharmacology, and
benefit-risk profile of a therapeutic agent by complementing data from
clinical studies.  

Responsibilities

Partners with CP lead to specify MIDD components of PMx plan, with
some supervision
• Supports CP Lead in planning, executing, and reporting of exploratory
PMx analyses in support of drug development decisions, with some
supervision
• Responsible for planning, executing, and reporting of formal PMx
analyses included in CSRs, HA submissions, and responses to
questions from HAs, with some supervision
• Serves as MIDD SME, and supports CP lead in the development of
therapeutic agents, with some supervision
• Contributes to maintenance and refinement of PMx infrastructure, with
some supervision
• Contributes to QPDA and cross-functional initiatives
• Manages PMx analyses performed by vendors, with some supervision
• Participates in interactions with health authorities as MIDD SME, with some supervision
• Collaborates with internal and external SMEs to develop and enhance
MIDD methodology and capability, with some supervision

Requirements:

Advanced Degree in relevant field (Ph.D., PharmD, MS)

For Ph.D. or PharmD level, 2+ years’ experience with demonstrated progression in PMx and CP knowledge

For Master’s level 5+ years’ experience with demonstrated progression in PMx and CP knowledge
• Basic quantitative data analysis, Data wrangling (merging and
transforming data), visualization, advan