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Epidemiology and Clinical Science Lead

2 months ago

Montreal, Quebec, Canada Pfizer Full time

Job Summary

The Clinical Research Director, Primary and Specialty Care will provide leadership in clinical epidemiological study execution, ensuring consistency of approach, conduct, result reporting, and oversight of core team activities within one or more specialty or primary asset programs. In collaboration with Scientific Affairs, Biostatistics group, and Clinical Affairs Operations, the Director will be responsible for execution and project management of their studies.

Key Responsibilities

  • Lead multiple end-to-end epidemiological studies across various SOPs, including protocol development, study design, data review and interpretation, study and/or program scientific and integrity oversight, safety review and communication, regulatory document preparation, and clinical study implementation oversight.
  • Represent Clinical Affairs line in program-wide functions, including Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams.
  • Provide matrix oversight for other RWE Platform Clinical Scientists within the program, reviewing work, developing staff, and providing ongoing feedback.
  • Collaborate with Medical/Scientific Leads and other team members on epidemiologic and Phase IV study planning activities, including contributing to annual Operating Plan and Lifecycle Plan development.
  • Provide CS leadership role in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits.
  • Represent TA Clinical Affairs and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and solutions for complex issues.

Requirements

  • Bachelor's or Master's degree in life sciences or health-related field with 10+ years of practical experience, or Ph.D. with 6+ years of experience.
  • Strong hands-on experience in epidemiological/observational study design, conduct, and analysis.
  • Significant experience leading operational and/or strategic study teams.
  • Experience working independently and collaborating with multiple functional groups within and outside the business line.
  • Experience within primary or specialty care.
  • Advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program objectives.
  • Advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field.
  • Independent authorship of clinical protocols and other clinical study documents.
  • Working knowledge of statistics, data analysis, and data interpretation.
  • Experience in managing external vendors for clinical and/or epidemiological studies.
  • Fluent in English writing, reading, and speaking, with exceptional written and oral communication and cross-functional collaborative skills.