Senior Director - Pharmacometrics

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Structure Networks, Inc.

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IT Staffing • Staffing • Contracting • Staff Augmentation • Consulting

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Description

• Work with cross functional stakeholders across Structure Therapeutics, supporting discovery, preclinical development, and clinical development of pipeline molecules. • Advocate for model informed drug development (MIDD) across drug discovery and development. • Promote the use of MIDD approaches to enhance decision making internally and through external presentations and collaborations. • Represent pharmacometrics within multidisciplinary teams and contribute to quantitative development programs and strong registrational packages. • Strategic leadership in design (analysis plans), oversight, analysis and reporting of pharmacometrics analysis. • May act as the author, reviewer and/or approver of modeling and simulation analysis plans, outputs and reports. • Develop mathematical models to evaluate pharmacokinetics and pharmacodynamics, conduct simulations to support trial design, including human dose prediction. • Conduct model-based meta-analysis, when appropriate. • Use artificial intelligence/machine learning, real world data, physiologically based pharmacokinetics, quantitative systems pharmacology, disease modeling or other tools for decision making, when appropriate. • Coordinate activities with contract vendors, consultants and pharmacometrics experts. • Contribute to pharmacometrics components in regulatory submissions, respond to regulatory authorities’ queries and represent the function at regulatory interactions, as appropriate. • Represent pharmacometrics on due diligence teams upon management request. • Create and contribute to the establishment of best practices for Clinical Pharmacology and Pharmacometrics activities - e.g. draft department work instructions, create protocol/report templates, training documents, and modeling and simulation infrastructure. • Lead pharmacometrics deliverables associated to competitive intelligence efforts.

Requirements

• Advanced training in Engineering, Mathematics, Statistics, Medicine or related fields. • 10+ years of drug development experience in the biotech/pharma industry. • Experience with dataset creation. • Application of pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric techniques (e.g. PopPK, PKPD, MBMA, statistical modeling), including the use of software’s such as NONMEM, R, Monolix, SAS, Matlab and Phoenix/Winonlin. • Pharmacometrics leadership experience representing the function in scientific team settings. • Experience with pharmacometrics aspects related to the development of small molecules. • Experience with regulatory filings (IND, NDA/BLA, MAA). • Scientific excellence as demonstrated through track record of publications or presentations on pharmacometrics applied to drug development. • Experience with cardiopulmonary, type 2 diabetes mellitus and obesity preferred. • Experience with PBPK and software’s such as Simcyp and GastroPlus preferred.