JOB DESCRIPTION

The Clinical Pharmacology Associate will analyze and report on clinical pharmacology studies. A professional with non-compartmental PK analysis experience working in the development organization. The Clinical Pharmacology Associate will be a key part of the Clinical Pharmacology function supporting clinical study execution teams. The Clinical Pharmacology Associate, will also be assisting Clinical Pharmacology and cross-functional clinical teams to ensure the successful execution of Clinical Pharmacology strategies.

Key Duties and Responsibilities

• Review pharmacokinetics concentration data & conduct non-compartmental PK analysis
• Assist in summarizing PK data and generating TFLs to support Clin Pharm updates
• Quality control (QC) reviews for NCA, TFLs, and CSR
• Prepare scientific reports and presentations related to clinical trials
• Collect, maintain and file study supportive documentation
• Manage operational elements of CQP studies with oversight.
• Assist in collaborations with Clinical Pharmacology CROs to support PK analysis for clinical study reports and relevant sections of regulatory filing documents

Required Experience and Education

• Bachelor’s degree, in Science, related to Field with +2 years’ experience in pharmaceutical industry, or Masters degree in pharmacology or related field
• 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
• Experience in supporting early-phase clinical trials.

LI-KM4

LI-Remote

• Review pharmacokinetics concentration data & conduct non-compartmental PK analysis
• Assist in summarizing PK data and generating TFLs to support Clin Pharm updates
• Quality control (QC) reviews for NCA, TFLs, and CSR
• Prepare scientific reports and presentations related to clinical trials
• Collect, maintain and file study supportive documentation
• Manage operational elements of CQP studies with oversight.
• Assist in collaborations with Clinical Pharmacology CROs to support PK analysis for clinical study reports and relevant sections of regulatory filing document