| Job Description | Job Description
Position Summary:
Perform PK modeling to optimize the development of controlled release formulations. Responsible for the design, analysis, interpretation and reporting of pharmacokinetic, bioavailability, bioequivalence and pharmacodynamic studies. Work with internal and external partners to identify CROs or conduct of clinical studies and bioanalytical activities.
Responsibilities:
• Ability to design and conduct PK and PD studies, conduct data analysis, and report results. Conduct simulations, develop in vitro-in vivo correlations and assist in selection of product formulations.
• Assist in the planning, implementation, and organization of regulatory IND and NDA filings.
• Assist in responding to regulatory questions
• Other related duties as assigned to meet departmental and Company objectives.
• Familiarity with CROs, procedures to obtain quotations, select appropriate sites, negotiate rates, and monitor studies
• Communicate with CROs, conduct site training as appropriate in the conduct of PK studies
• Understanding of bioanalytical methods and validation
Requirements:
• Experience with WinNonlin
• Experience in Brand pharmaceutical industry is a must.
• Ph.D. or Pharm D. with 3-5 years of relevant work experience in Clinical Pharmacokinetics/Biopharmaceutics, clinical pharmacology, or in a related Pharmaceutical Sciences field with PK and PD modeling knowledge/skills.
• Knowledge in biopharmaceutics, drug metabolism, formulation, and analytical chemistry is needed.
• Knowledge of preclinical pharmacokinetic principles |
| | Company | | Impax Laboratories | Job Code | | State or Province | | California | | |
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