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