(Associate) Director Clinical Pharmacology - Europe
Certara, L.P
GB
10h ago

Responsibilities

  • Collaborates in teams both internally and with clients as a scientific advisor on clinical pharmacology, clinical development, model-
  • informed drug development issues.

  • Reviews and interprets client material.
  • Provides scientific, logistic and strategic input into clinical trial protocols and modeling strategies
  • Performs or supervises graphical explorations of pharmacokinetic and pharmacodynamics data
  • Performs or supervises non-compartmental pharmacokinetic analyses
  • May perform model-based evaluations of pharmacokinetic and / or pharmacodynamics data
  • Writes and compiles reports and other documents summarizing advice both internally and for clients.
  • Participates in business development initiatives.
  • Supports the preparation of project proposals for prospective and existing clients.
  • Education, Experience, Training, and Knowledge :

  • 4+ (Associate Director) or 7+ (Director) or years of drug development experience including clinical pharmacology expertise in the pharmaceutical industry
  • Broad medical and small molecule as well as biologics therapeutics experience and / or the ability to quickly acquire knowledge and understanding of diseases
  • Experience in developing clinical trial protocols and providing input on clinical pharmacology plans, model-informed drug development strategies and preparation of regulatory submissions (e.
  • g. INDs, NDAs, BLAs and / or significant sNDAs / sBLAs)

  • Proficient in Microsoft Word and PowerPoint
  • Proficient in WinNonlin, and graphical and statistical software (preferably R)
  • Functional understanding of the application of model based tools (e.g. Phoenix / NLME, NONMEM)
  • Skills & Abilities

  • Thorough understanding of the drug development process and a good appetite for the opportunities for innovation through application of quantitative clinical pharmacology, pharmacometric and health economics concepts
  • Ability to build effective relationships with clients as well as with internal stakeholders and colleagues.
  • Excellent written, verbal and inter-personal communications skills
  • Strong team player skills; must be able to work well with a team in a multidisciplinary environment
  • Apply
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