Director role in Quantitative Pharmacology applying quantitative approaches for drug development in infectious diseases and vaccines. Leading cross-functional teams and developing regulatory strategies with minimal supervision.
Responsibilities
Apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics
Inform dose selection and go/no-go decisions
Shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications
Lead QP2 efforts on drug development programs and author strategic documents
Serve as an expert representative for QP2 on teams developing infectious disease or vaccine assets
Mentor and/or supervise junior colleagues to develop capabilities in drug development
Requirements
a Ph.D. or equivalent degree with at least seven years of experience OR (a PharmD or equivalent degree 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 or academia)
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar)
Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days
Job title
Director, Infectious Diseases and Vaccines, Quantitative Pharmacology, Pharmacometrics
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