Clinical Scientist Director Primary and Specialty Care

4 weeks ago


Montreal, Quebec, Canada Pfizer Full time
ROLE SUMMARY

The Clinical Scientist Director will provide strategic 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, and Clinical Affairs Operations, the Director will be responsible for the execution and project management of epidemiological studies. The Director will lead a global team and may support all types of Evidence Generation projects in the US, Europe, Developed, and Emerging Markets.

KEY RESPONSIBILITIES
  1. The Clinical Scientist Director will lead multiple end-to-end epidemiological studies across various SOPs, including protocol development, study design, data review, interpretation, study and/or program scientific and integrity oversight, safety review, regulatory document preparation, and clinical study implementation oversight.
  2. The Director will represent Clinical Affairs in program-wide functions, including Clinical Project Teams, Medical Sub Committees, Clinical Study Teams, Asset Teams, Program Teams, and Regulatory Strategy teams.
  3. The Director may provide matrix oversight for other Clinical Scientists within the program, reviewing work, developing staff, and providing ongoing feedback.
  4. The Director will use expert knowledge of epidemiologic and observational aspects of trials to provide oversight of operational strategic partner involvement at a program or study level.
  5. The Director will influence management decisions and be viewed as the Subject Matter Expert on Clinical Scientist decisions impacting a program and potentially the Medical/Scientific Affairs groups.
  6. The Director will 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.
  7. The Director will provide Clinical Scientist leadership in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits.
BASIC QUALIFICATIONS

Candidates must demonstrate a breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

  • BA/BSc Degree in life sciences or health-related field with 10+ years of practical experience or MSc/MPH with 8+ years or PhD with 6+ years.
  • Strong hands-on experience in epidemiological/observational study design, conduct, and analysis.
  • Significant experience leading operational and/or strategic study teams.
  • Significant experience working independently and collaborating with multiple functional groups within and outside the business line.
  • Experience within primary or specialty care.
  • Demonstrated advanced ability and level of experience 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.
  • Independently authored 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.
PREFERRED QUALIFICATIONS
  • MSc/MPH or PhD preferred.
  • Experience working in a global setting.
  • Proficient in MS Office, including Teams, Word, Excel, and PowerPoint.
  • Knowledge or experience in research for Specialty or Primary Care TA is desirable.
  • Has worked in Industry.


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