What are the responsibilities and job description for the Pharmaceutical Kinetics Specialist position at Revolution Medicines?
Revolution Medicines Overview
Revolution Medicines is a clinical-stage precision oncology company that focuses on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. Our research and development pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.
The Opportunity
This is a unique opportunity for an experienced professional with bioanalytical GxP knowledge and non-compartmental PK analysis expertise. As a Clinical PK Manager, you will be a key part of the Clinical Pharmacology team responsible for overseeing Bioanalytical Contract Research Organization (CRO) activities and representing the Clinical Pharmacology function at clinical study execution teams. You will bridge the gap between Clinical Pharmacology and cross-functional clinical teams to ensure successful Clinical Pharmacology strategy execution.
Responsibilities
Liaise with Clinical Pharmacology Project Leads to design and review pharmacokinetics components of clinical protocols, lab manuals, and other study-related documents. Manage technical oversight of regulated bioanalysis activities for assigned CROs. Facilitate sample reconciliation and manage sample analysis timelines. Review method validation protocols, PK sample analysis plans, and study reports. Conduct non-compartmental PK analysis, summarize data, and present at project team meetings to drive critical study decisions. Collaborate with CROs/consultants to support PK analysis for clinical study reports and regulatory filing documents.
Revolution Medicines is a clinical-stage precision oncology company that focuses on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. Our research and development pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies.
The Opportunity
This is a unique opportunity for an experienced professional with bioanalytical GxP knowledge and non-compartmental PK analysis expertise. As a Clinical PK Manager, you will be a key part of the Clinical Pharmacology team responsible for overseeing Bioanalytical Contract Research Organization (CRO) activities and representing the Clinical Pharmacology function at clinical study execution teams. You will bridge the gap between Clinical Pharmacology and cross-functional clinical teams to ensure successful Clinical Pharmacology strategy execution.
Responsibilities
Liaise with Clinical Pharmacology Project Leads to design and review pharmacokinetics components of clinical protocols, lab manuals, and other study-related documents. Manage technical oversight of regulated bioanalysis activities for assigned CROs. Facilitate sample reconciliation and manage sample analysis timelines. Review method validation protocols, PK sample analysis plans, and study reports. Conduct non-compartmental PK analysis, summarize data, and present at project team meetings to drive critical study decisions. Collaborate with CROs/consultants to support PK analysis for clinical study reports and regulatory filing documents.
