proactively identify and provide significant Pharmacometrics (PMx) contributions
address strategically important program needs for research and development programs
communicate complex PMx strategies and results to the development team
independently design, conduct and oversee PMx analysis plans
author PMx contributions to regulatory documentation
perform additional analyses to support regulatory interactions
draft and review documentation for accuracy, clarity and messaging
work directly with development or Research teams on PMx elements of program strategy
contribute to the drafting of PMx program strategies to support standard programs
support a study team on PMx deliverables and objectives

A PhD in Biology, Pharmacology, Engineering or a Pharmacy (Pharm.D.), Medicine (MD) degree
at least 6 years of relevant Clinical Pharmacology experience
understanding of PMx concepts and techniques (advanced pharmacokinetics, advanced pharmacological principles, non-compartmental analysis methods, compartmental modeling, translational modelling/pharmacology, Exposure-Responses analysis methods, Nonlinear Mixed Effects modeling, logistic regression, survival analysis, Bayesian approaches, disease modelling/QSP)
knowledge of innovative PMx methodologies applicable to clinical trials (survival analysis, stratified or covariate analyses, and strategies for handling missing data)
good regulatory experience (authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory review and approval of BLA or equivalent)
ability to formulate PMx objectives, design, and analyses for complex clinical projects
proficient in MS-Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Associate Director, Clinical Pharmacology

Key skills