Principal Research Scientist - Modeling and Simulation
Core
Lead efforts to build in silico drug models describing the relationship between drug exposure and response (pharmacodynamic) for desired and undesired effects to support formulation and early-stage clinical development.
Role type
Principal Research Scientist (Modeling and Simulation)
Builds
In silico drug models for exposure-response relationships
Domain
Pharmaceutical Sciences / Quantitative Pharmacology / Biopharmaceutics
Deliverable
production ML models
Required skills
PK/PD modeling and simulation, population PK, PBPK modeling, statistical modeling, data manipulation, SAS, R, Phoenix WNL, GastroPlus, SimCyp
Preferred skills
Biologics modeling, gene therapy, general programming (Matlab, Berkeley Madonna, ADAPT)
Technologies
Phoenix WNL, GastroPlus, SimCyp, SAS, R
Responsibilities
Apply PK and PK/PD modeling/simulation to guide design of in vivo preclinical animal experiments and early-stage clinical trials; Identify opportunities to apply and develop modeling and simulation strategies across the R&D portfolio with a focus on ophthalmology and aesthetics/dermatology; Integrate M&S knowledge to contribute to optimizing translational sciences strategies; Analysis of PK/PD data through sophisticated mathematical and statistical modeling to support dose selection, study design and proof-of-concept; Conduct and integrate data analyses to support IND, CTA, IMPD, NDA, and BLA filing and regulatory correspondences; Design and provide scientific oversight of preclinical PK/TK studies.
Seniority
Principal, hands-on IC with strategic oversight