Senior Pharmacokenticist

DR VINCE CLINICAL RESEARCH PA

Overland Park, KS Job Details 20 hours ago Qualifications Statistics Pharmaceutical regulatory compliance Drug regulation Physiology knowledge ICH guidelines Pharmaceutical company experience Clinical quality assurance standards Pharmacokinetics Clinical data analysis Pharmaceutical research experience Data analysis software Full Job Description

JOB TITLE

Senior Pharmacokineticist

REPORTS TO

Associate Director, Pharmacokinetics

DIRECT REPORTS

Not Applicable

POSITION SUMMARY

The Senior Pharmacokineticist serves as the lead or support for clinical Pharmacokinetic (PK) and Pharmacodynamic (PD) (hereafter referred to as "PK") planning, analysis, and interpretation in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).

KEY RESPONSIBILITIES

Participate in the protocol development, including study design, endpoints selection, sample size determination, and writing/reviewing the PK analysis methods sections Support Case Report Form (CRF) design and review relevant data management documents Develop PK portion of Statistical Analysis Plan (SAP) or PK Analysis Plan (PKAP) along with relevant Tables, Listings, Figures (TLF) shells Analyze, interpret, summarize, and present PK data to sponsor and/or medical writer for use in Clinical Study Report (CSR) or other summary reports Conduct Quality Control (QC) review of PK analyses, text, and outputs (e.g., PK TLFs) Assists in the development of SOPs and guidelines for the PK department

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 noncompartmental analysis, including experience with software applications (e.g., 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 (e.g., SAS, R) Additional knowledge and/or experience in the application of routine PK compartmental modeling software systems and/or physiologically-based PK modeling