Structure Networks, Inc.
IT Staffing • Staffing • Contracting • Staff Augmentation • Consulting
51 - 200 employees
Founded 2001
Senior Director - Pharmacometrics
2 days ago
Structure Networks, Inc.
IT Staffing • Staffing • Contracting • Staff Augmentation • Consulting
51 - 200 employees
Founded 2001
Description
• Senior Director, Pharmacometrics will work with cross functional stakeholders across Structure Therapeutics. • Supporting discovery, preclinical development, and clinical development of pipeline molecules. • Accountable for the Pharmacometrics aspects of regulatory filings along with presentation of results and key messages to internal teams, executive management, health authorities and external collaborators. • Report to the VP, Clinical Pharmacology and Pharmacometrics. • 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. • 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. • Coordinate activities with contract vendors, consultants and pharmacometrics experts. • Create and contribute to the establishment of best practices for Clinical Pharmacology and Pharmacometrics activities.
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 a 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. • Travel Around 15% for conferences, with a potential to travel to office in China and one week a month to the SSF, CA office.
Benefits
• bonus • equity • benefits
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