Director, Nonclinical and Clinical Pharmacokinetics

Location
Emeryville, California (US)
Posted
Apr 26, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

The candidate will reside in the Research Department and will collaborate on project teams to provide key pharmacokinetic expertise to all stages of nonclinical and clinical development.  In this capacity, the candidate will contribute to the design, execution, and analysis of  nonclinical and clinical studies and the analysis and interpretation of pharmacokinetic data. The successful candidate will possess the relevant background and experience in pharmacokinetics in order to effectively execute program objectives.  The candidate will be based in Emeryville, CA and will report to the Vice President, Research. 

Responsibilities:

  • Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic studies across all programs
    • Contribute to the design, execution, and interpretation of nonclinical studies, including ADME, CYP inhibition/induction, transporter, PK/PD, and toxicokinetic studies
    • Contribute to design, execution, and interpretation of pharmacokinetic components for clinical studies, including first-in-human, bioavailability and/or bioequivalence, drug-drug interaction, and population PK studies
  • Provide technical leadership for pharmacology topics at project meetings and with partners, consultants and regulatory agencies
  • Understand and effectively apply appropriate regulatory guidelines to drug development
  • Review and interpret scientific literature to guide program objectives
  • Contribute to intellectual property strategy and the drafting of patents
  • Interact very closely with the following functions to ensure consistency of development strategies:
    • Research
    • Clinical Research
    • Clinical Operations
    • Pharmaceutical Development
    • Regulatory
    • Commercial
    • Intellectual Property
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations

Qualifications:

  • MD, PhD, or PharmD in a related field with a specific focus on pharmacokinetics/pharmacology
  • 10+ years experience in a drug development environment within biopharmaceutical industry
  • Strong understanding of pharmacokinetic theory, compartmental and noncompartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches
  • Proficiency with the appropriate data analysis software and tools, including WinNonlin and GastroPlus
  • Extensive experience producing models and simulations of single and repeat bolus dosing, infusions and extended or modified release formulations
  • Strong research background in pharmacokinetics, as evidenced by patents and/or peer reviewed publications
  • Previous experience in preparing regulatory submissions, including the pharmacokinetic and pharmacodynamic portion of NDAs and INDs and responding to regulatory questions related to pharmacology and pharmacodynamics
  • Strong quantitative and analytical skills
  • Ability to prioritize and drive results with high scientific rigor
  • Excellent verbal and written communication skills
  • Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology
  • Successful experience in fast-paced entrepreneurial environment
  • Fit with Adamas culture and values