Toronto, Ontario – Clinical Research Scientist

Location: Toronto, Ontario

Reports to: Manager Medical Writing and Data Management

Duties and Responsibilities:

  • Write Phase 1-2a and Bioequivalence Study Protocols and Informed Consent Forms.
  • Perform Literature search, NDA review and scientific discussion relevant for designing a study protocol for BE and Phase 1-2a (Proof of concept)
  • Review non-clinical data in preparation to transition to the First in Human clinical trial.
  • Interact efficiently with PK Scientists and Biostatisticians to make sure that the study design is in line with the most updated regulatory and scientific requirements
  • Interact with Institutional Review Boards with respect to Protocols, Informed Consent Forms and other documents as required.
  • Assist in the development of Standard Operating Procedures (SOPs) and guidelines linked with the department activities.
  • Assist with the preparation for Regulatory agencies and participate if needed in any discussion with the inspectors.
  • Work closely with scientific, clinical personnel, and the Principal Investigator to ensure that clinical study protocol and other scientific documents are produced to the standard required by Good Clinical Practice (GCP), SOP and other applicable guidelines..
  • Establish optimal timelines with external departments in order to meet study projects timelines.
  • Perform other work within the Scientific Affairs department as needed.

Qualifications:

  • Minimum University degree, M.Sc. (i.e. Pharmacy, Pharmacology or other Life Sciences relevant degree).  PhD candidate may be considered
  • At least 2 years of Scientific Protocol design and Writing experience
  • Experience in an CRO environment is an asset preferably in the conduct of Phase I and Bioequivalence studies
  • Excellent scientific writing skills.
  • Excellent interpersonal and communication skills.
  • Attentive to details, good initiative and able to work with changing priorities under tight timelines.
  • Previous participation in Scientific discussion with Agencies (e.g. Scientific Advice meeting in EU, Pre-IND packaging and meeting with FDA)
  • Other scientific roles and experience may be considered.

Please send your resume to resumes@biopharmaservices.com