SQRL · 5 days ago
Director of Pharmacometrics (Clinical Research)
SQRL is a nonprofit organization focused on improving human health through innovative partnerships and processes. The role involves overseeing clinical pharmacology and modeling components of drug development plans while managing the Pharmacometrics Team within the Quantitative Medicine Program.
Responsibilities
Plans and directs clinical pharmacology and modeling and simulation components of programs
Works with multifunctional internal and external teams to design, deliver and report the assigned clinical pharmacology and modeling and simulation tasks
Accountable for the development and implementation of modeling and simulation plans based on agreed upon best practices (i.e. model-based drug development)
Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to inform optimization of doses, dosage regimens and study designs
Responsible for appropriate summarization and interpretation of results of data analyses with respect to their impact on development of quantitative drug development tools
Prepares scientific summaries and reports which will be used for regulatory submissions and publications
Provides quantitative medicine, clinical pharmacology support and leadership in the preparation and defense of regulatory submissions
Qualification
Required
PhD or equivalent
Experience modeling and simulation
Experience in Pharmacometrics, clinical pharmacology, PK/PD, MIDD, Quantitative Medicine
Experience coding software platforms such as R, NONMEM
Knowledge of phase I-III studies (not just pre-clinical)
Experience managing a team
Preferred
Experience coding software platforms: Phoenix, WinNonLin, SIMCYP
Benefits
Fully covered healthcare premiums
Retirement account with match
20 days PTO
Week long holiday closure
And more!