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Senior Clinical Research Scientist

July 14 2017
Categories Clinical research, Pharmacokinetics, Pharmacology
Montreal, QC

In collaboration with clinical research scientists, the senior clinical research scientist ensures that bioequivalence studies, project evaluations and due diligence are as per the requirements from different health authorities and company's objectives. Provide creative suggestions of a study design for a complex drug product, e.g. complicated pharmacokinetics or formulations. The senior clinical research scientist is the primary contact with regulatory agencies for bioequivalence and clinical study queries. The senior clinical research scientist is responsible for outsourcing the bioequivalence studies.

This role will also be responsible for performing pharmacokinetic / pharmacodynamic analyses of data generated through clinical and preclinical studies.

The main responsibilities of this position are as follows:

  • Be aware and have an understanding of the regulatory guidelines from health authorities (Health Canada, EMA and FDA) as well as be aware and understand GCP and GLP requirements.
  • Perform literature, clinical and non-clinical data searches/reviews as necessary to obtain background information for review and preparation of study-related documents.
  • Execute pharmacokinetic / pharmacodynamic analyses of clinical study data and non-clinical data; perform compartmental and non-compartmental analyses using WinNonlin.
  • Responsible for study design for clinical and non-clinical pharmacokinetic / bioequivalence studies
  • Responsible for the scientific assessment of projects including risk assessment analysis, costs, and timelines and prepare a technical document to support approval of early stage pipeline project approval
  • Provide justification and prepare written technical documents for queries to health authorities 
  • Prepare written responses to regulatory authorities' clarifaxes and deficiency letters. 
  • Contribute scientific support to other departments and colleagues 
  • Develop, implement and maintain SOPS related to clinical pharmacokinetics, biometrics and report writing activities. 
  • Be involved in the preparation of regulatory inspections.
  • Perform quality control review of analysis/documents prepared by other scientists.
  • Work closely with Project Management and Regulatory Affairs. 
  • Prioritize own work and manage project schedule to meet delivery deadlines.
  • Train and provide guidance to new or junior employees
  • Responsible for negotiating the price and for the outsourcing of bioequivalence studies


  • Ph.D. degree in pharmacology, pharmacokinetics, or other related life-science field with 1 year of experience or MSc degree with minimum 5 years experience in the pharmaceutical industry as a scientist.
  • Experience in clinical pharmacology and pharmacokinetics in the industry is an assest.

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