T
he ideal candidate will have
strong
background in pharmacokinetics and translational modeling. You will
participate
in implementing innovative and quantitative approaches to advance clinical drug development.
Developing, qualifying, and applying mechanistic PBPK models
using in
vitro, preclinical, clinical, and literature data to support clinical development decisions across therapy
areas
.
In addition, you will have opportunities to contribute to broader areas within Clinical Pharmacology & Quantitative Pharmacology
(CPQP)
as
per
your experience
, interests,
and
expertise
dictate
.
Typical Accountabilities
Utilize
physiologically-based
pharmacokinetic (
PBPK
)
and translational modeling tools to enable clinical PK projections for
drug-drug interactions (
DDIs
)
, pediatric and other specific populations, and other clinical development questions
Collaborate with
Drug Metabolism and Pharmacokinetic (
DMPK
) Scientists
and Clinical Pharmacology scientists to generate these mechanistic models
Develop fit-for-purpose, qualified PBPK models suitable for internal decision-making and regulatory use, including support for
submission
documentation and health authority
interactions
.
Communicate
clearly and effectively both internally and externally on topics related to PBPK clinical DDI and pediatric and other specific populations predictions
Keep up to date with emerging literature, modeling science, and regulatory expectations
Education, Qualifications,