Description:
This is a unique opportunity for a professional with bioanalytical GxP knowledge and non-compartmental PK analysis experience. The Clinical PK Manager will be a key part of the Clinical Pharmacology team responsible for Bioanalytical Contract Research Organization (CRO) oversight and represent the 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 Skills, Experience, 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 experience.
- 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.
- Prior experience in non-compartmental PK analysis using Phoenix WinNonlin.
- 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.