Clinical PK Manager

Company: Revolution Medicines
Location: Redwood City
Posted on: January 14, 2025

Job Description:

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. - The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The Opportunity:This is a unique opportunity for a professional with bioanalytical GxP knowledge and non-compartmental PK analysis experience. Clinical PK Manager will be a key part of the Clinical Pharmacology team responsible for Bioanalytical Contract Research Organization (CRO) oversight and represent Clinical Pharmacology function at clinical study execution teams. As a clinical PK manager, you will also be a bridge between Clinical Pharmacology and cross-functional clinical teams to ensure the successful execution of Clinical Pharmacology strategies.Liaise with Clinical Pharmacology Project Leads to design and review the pharmacokinetics components of a clinical protocol, lab manual and other study associated documents.Manage and provide technical oversight to bioanalytical CROs on regulated bioanalysis.Facilitate clinical PK sample reconciliation and manage sample analysis timeline.Review method validation protocols, PK sample analysis plans and study reports.Review pharmacokinetic concentration data, conduct non-compartmental PK analysis, summarize data and present at project team meetings to drive critical study decisions.Manage collaboration with clinical pharmacology CROs/consultants to support PK analysis for clinical study reports and relevant sections of regulatory filing documents. -Required Experience, Skills, and Education:MS in Analytical Chemistry, Pharmacokinetics, drug metabolism or a related scientific discipline with 5 years of relevant industry experience, or BS with over 8 years of relevant industry experiencePrior experience in non-compartmental PK analysis using Phoenix WinNonlin.In-depth knowledge and hands-on experience with LC/MS/MS and quantitative analysis of small molecules in complex biological matrices.Good understanding of regulatory guidelines for regulated bioanalysis.Excellent interpersonal, oral, and written communication skills.Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment.Preferred Skills:Hands on experience in GLP.Experience in supervising BA CRO.Experience in supporting BA / NCA in Phase 1, Phase 2 clinical trials.The base salary range for this full-time position is $138,000 to $172,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our -CCPA Notice -and -Privacy Policy. -For additional information, please contact -privacy@revmed.com.#LI-Hybrid - -#LI-CT1

Keywords: Revolution Medicines, San Jose , Clinical PK Manager, Executive , Redwood City, California