Directors apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies
Job Summary
Directors apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies.
Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents.
The Director is a skilled quantitative drug and vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development.
Matching Summary
Directors apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies.
Salary
Base: $190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, compassionate and sick days
Skills & Requirements
Must-have
Quantitative PK/PD modeling
Model-based drug development
Regulatory strategy and submissions
Infectious disease and vaccine assets
PK/PD and QSP modeling
Nice-to-have
Leadership and communication skills
Interdisciplinary collaboration
Mentoring junior colleagues
External vendor and partner collaboration
Key Requirements
Ph.D. or equivalent degree with at least seven years of experience
PharmD or equivalent degree with at least nine years of experience
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field
Experience with modeling programming language(s)
Direct experience in regulatory interactions and filings