The Infectious Disease and Vaccines group in the department of Quantitative Pharmacology and Pharmacometrics (QP2) needs to apply quantitative approaches to enable drug-development decision-making from drug discovery through approval.
Requirements
- Proficiency in R, NONMEM, Matlab, Python, or a similar programming language
- Proficiency in written and verbal communication
- Knowledge of infectious diseases
- Experience performing population PK and/or PK/PD analyses
- Experience with standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix.)
- Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
- Scientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeutics
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
- Develop a comprehensive understanding of global regulatory expectations of drug and vaccine development, including clinical trial design, clinical pharmacology, biomarker plans, and model-based drug development approaches.
- Develop leadership skills in areas such as mentoring, managing a program, project, or initiative.
- Collaboration within the group and with other functional areas, as well as with external vendors and partners, to create an aligned, quantitative framework to impact decisions of drug development teams is also crucial.
Other
- 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.
- Excellent communication skills both written and verbal are required, including the ability to clearly present scientific data in cross functional group settings.
- The ideal candidate is collaborative and eager to learn.
- Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
