#x 9; Design and conduct in vitro ADME studies, interpret and report data. Interpret and summarize DMPK experimental data related to the in vitro ADME, in vivo animal PK. Collaborate with Discovery Chemistry for the design and optimization of ADME properties from lead generation to candidate nomination. Collaborate with Discovery Chemistry and Biology teams for the optimization of new compounds and support project progression. Collaborate with Biology for the design of pharmacology studies, prov... more details
Kelly is looking for a DMPK Contract Lead who will design and conduct ADME studies, interpret and report data, collaborate with other teams, and provide input for regulatory documents. Our client develops novel medicines for metabolic and age-related disorders, located in Thousand Oaks, CA. Responsibilities:
Design and conduct in vitro ADME studies, interpret and report data.
Interpret and summarize DMPK experimental data related to the in vitro ADME, in vivo animal PK.
Collaborate with Discovery Chemistry for the design and optimization of ADME properties from lead generation to candidate nomination.
Collaborate with Discovery Chemistry and Biology teams for the optimization of new compounds and support project progression.
Collaborate with Biology for the design of pharmacology studies, providing dosing regimens and timepoints for PK and PD sampling.
Analyze PK and PD data and establish PK/PD relationship using various modeling approaches.
Draft and provide content for regulatory documents including CTD, IND Updates, clinical study report, investigator brochure, etc.
Ensure that all assigned studies are conducted according to GCPs, relevant SOPs and best working practices.
Liaise with external modeling and simulation scientists in CROs to conduct specialized PK/PD and pharmacometrics analysis.
Requirements:
PhD in clinical pharmacology/pharmacokinetics-pharmacodynamics with minimum 5 years of related industry experience.
Hands-on pharmacokinetics and pharmacodynamics expertise, with knowledge of advanced modeling and simulation methodologies.
Experience in writing regulatory documents for NDA filings and have gone through multiple filings in US and EU.
Proven oral and written communication skills.
This is a contract position requiring 10-20 hours of work.
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