Senior Specialist, Quantitative Pharmacology and Pharmacometrics - Infectious Disease and Vaccines

Role Summary

Senior Specialists in the Infectious Disease and Vaccines group in the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to enable drug-development decision-making from drug discovery through approval. The role involves collaborating with multidisciplinary teams and developing expertise in pharmacometrics and related areas to support drug and vaccine development.

Responsibilities

• Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new drug and vaccine candidates
• Developing and executing pharmacokinetics and pharmacodynamics modelling approaches, such as noncompartmental analysis, population pharmacokinetic, exposure-response, quantitative system pharmacology, viral dynamics, model-based meta-analysis, and other model-based analyses
• Perform clinical trial simulations to inform dose selection and go/no-go decisions
• Serve as a QP2 representative while being mentored by QP2 senior staff on drug and vaccine development teams to manage functional deliverables for assigned programs

Education

• A Ph.D. or equivalent degree - OR - a PharmD or equivalent degree with at least two years of experience - OR - a MS or equivalent degree with at least four years of experience, where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia
• An educational background in PK/PD, pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

Qualifications

• Required: Proficiency in R, NONMEM, Matlab, Python, or a similar programming language
• Required: Proficiency in written and verbal communication
• Preferred: Knowledge of infectious diseases
• Preferred: Experience performing population PK and/or PK/PD analyses
• Preferred: Experience with standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix.)
• Preferred: Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
• Preferred: Scientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeutics