POSITION SUMMARY:

We are seeking an experienced, skilled, and detail-oriented pharmacokinetic (PK) scientist to join our growing team. The ideal candidate will have experience in supporting early phase clinical pharmacology studies as well as complex PK/pharmacodynamic (PD) studies. The role will support the planning, analysis, and interpretation of PK/PD results to aid in the development of innovative solutions in healthcare and research.

REQUIRED QUALIFICATIONS:

• PharmD or PhD in pharmacokinetics or related field with 3+ years clinical research experience in pharmaceutical/biotech industry (or MS with commensurate experience)
• Competence in performing non-compartmental analysis, including experience with software applications (eg, Phoenix WinNonlin or R)
• Knowledge of PK/PD principles with relevant experience in multiple therapeutic areas
• Understanding of statistical methodologies used in clinical trials and interpretation of results
• Knowledge of FDA/ICH regulations/guidelines
• Excellent verbal and written communication skills and interpersonal skills

PREFERRED QUALIFICATIONS:

• Experience with additional software for the generation of PK outputs (eg, SAS, R)
• Additional knowledge and/or experience in the application of routine PK compartmental modeling software systems and/or physiologically-based PK modeling

• Participate in protocol development, including study design, endpoints selection, sample size determination, and writing/reviewing the PK analysis methods sections
• Support design and review of relevant data management documents, as applicable
• Develop PK/PD portion of Statistical Analysis Plan (SAP) or PK Analysis Plan (PKAP) along with relevant Table, Figure, and Listing (TFL) shells
• Analyze, interpret, summarize, and present PK/PD data to sponsors and/or medical writers for use in a Clinical Study Report (CSR) or other summary reports
• Conduct Quality Control (QC) review of PK analyses, text, and outputs (eg, PK TFLs)
• Assists in the development of standard operating procedures (SOPs) and guidelines for the PK department