Serving as an expert representative for QP2 -IO on Oncology development teams.
Framing critical questions and strategy for optimizing model-based analyses on programs.
Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling.
Strategizing and executing modeling of tumor size and survival.
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory meetings.
Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.

Ph.D. with at least seven years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering
Masters or PharmD, with at least nine years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development
Demonstrated impact with applications of pharmacometrics methods
Experience in IND, NDA and other submissions to global regulatory agencies
Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
Proficiency in R, NONMEM,MATLAB, Monolix or other modeling software
Professional working proficiency in written and verbal communication.

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Director, Quantitative Pharmacology and Pharmacometrics – Oncology

Key skills