Senior Pharmacokenticist

JOB TITLE: Senior PharmacokineticistREPORTS TO: Associate Director, PharmacokineticsDIRECT REPORTS: Not ApplicablePOSITION 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 sectionsSupport Case Report Form (CRF) design and review relevant data management documentsDevelop PK portion of Statistical Analysis Plan (SAP) or PK Analysis Plan(PKAP) along with relevant Tables, Listings, Figures (TLF) shellsAnalyze, interpret, summarize, and present PK data to sponsor and/or medical writer for use in Clinical Study Report (CSR) or other summary reportsConduct 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 departmentREQUIRED 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 areasUnderstanding of statistical methodologies used in clinical trials and interpretation of resultsKnowledge of FDA/ICH regulations/guidelinesExcellent verbal and written communication skills, and interpersonal skillsPREFERRED 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 #J-18808-Ljbffr Priority Dispatch Corp.