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

Overview

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. Senior Specialists work in collaborative teams and with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform the primary responsibilities of the role, including: 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; performing clinical trial simulations to inform dose selection and go/no-go decisions; and serving as a QP2 representative while mentored by senior staff on drug and vaccine development teams to manage functional deliverables for assigned programs.

You will develop an understanding of global regulatory expectations for drug and vaccine development, including clinical trial design, clinical pharmacology, biomarker plans, and model-based drug development approaches. You will also develop leadership skills in mentoring, program management, and collaboration with internal teams and external partners to create an aligned, quantitative framework to impact decisions of drug development teams. The role requires clear written and verbal communication to present scientific data in cross-functional group settings.

• Apply quantitative approaches to develop translational clinical PK/PD for new drug and vaccine candidates.
• Develop and execute PK/PD modelling approaches, such as noncompartmental analysis, population PK, 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.
• Represent QP2 on drug and vaccine development teams and manage functional deliverables for assigned programs under mentorship.
• Develop understanding of regulatory expectations and contribute to study designs and biomarker plans; build leadership skills in mentoring and program management.
• Collaborate within the group and with other functional areas, as well as with external vendors and partners, to create a aligned, quantitative framework to impact development decisions.
• Communicate scientific data clearly in written and verbal form in cross-functional settings.

Minimum required education: A Ph.D. or equivalent degree; OR a Pharm

D or equivalent degree with at least two years of experience; OR an MS or equivalent degree with at least four years of experience. Educational background in PK/PD, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

Required experience and skills:
Proficiency in R, NONMEM, Matlab, Python, or a similar programming language; proficiency in written and verbal communication.

Preferred experience and skills:
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, data analysis/interpretation, and statistics; scientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeutics.

Salary range: $ – $. The range represents the employer’s good-faith belief of the pay for this role at the time of posting. Actual compensation is based on factors including education, experience, location, government requirements, and business needs. Eligible for annual bonus and long-term incentives, if applicable. A comprehensive benefits package is offered, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days.

More information about benefits is available on the company careers page.

US Hybrid Work Model:
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