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Associate Director, Clinical Pharmacology - United States  

Intercept (company)


Posted on : 18 May 2017

Project Description

description:
the Associate Director, Clinical pharmacology serves as the Clinical pharmacologist on program teams and execution of Clinical pharmacology plans that characterize the adme and pk/pd of the drug candidate, providing rationale for dose regimen selection and identifying circumstances where dose adjustment should be considered. the position will also be a resource to teams for guidance on all matters related to Clinical pharmacology and Pharmacokinetics, Pharmacodynamics, and drug Metabolism.



essential functions:
  • responsible for providing Clinical pharmacology support along with absorption, distribution, Metabolism and excretion (adme) input and scientific opinion to project teams, line management, and governance bodies.
  • provide Clinical pharmacology study efforts (e.g., study design, science)" rel="nofollow">Protocol concepts/science)" rel="nofollow">Protocols preparation, Clinical phase oversight, and reporting) within assigned programs to yield high value pk/pd insight for future critical decisions. 
  • analyzes results and interprets and recommends action based on study results. 
  • collaborates with clinicians, quantitative sciences and Clinical Operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes. 
  • identifies and efficiently resolves program and study-specific issues. 
  • works with study and program teams to achieve program goals and provides deliverables in approved timeframes. 
  • applies best regulatory practices and drug development precedent to assigned programs. 
  •  supports regulatory input for drug filings related to Clinical pharmacology



qualifications:



required knowledge and abilities:
  • strong verbal and written Communication skills are essential
  • able to facilitate activities across many disciplines represented on drug development project teams
  • ability to work in a fast-paced environment
  • excellent organization and multi-tasking skills
  • strong interpersonal skills and problem-solving capabilities
  • proven meeting Planning and team facilitation skills.

Locations

San Diego CA United States

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