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Director of Clinical Epidemiology
3 months ago
POSITION OVERVIEW
The Clinical Scientist (CS) will spearhead the execution of clinical epidemiological studies, ensuring a uniform approach, conduct, and reporting of results while overseeing core team activities across various specialty or primary asset programs. Collaborating closely with the Scientific Affairs (SA) Biostatistics team and Clinical Affairs (CA) Operations, the CS will manage the execution and project oversight of these studies. This global role encompasses support for all types of Evidence Generation projects across diverse markets, including the US, Europe, and both Developed and Emerging Markets. As the leader of the Study Core Team, the CS will guide a matrix organization comprising Epidemiology, Biostatistics, Clinical Operations, Medical/Scientific Affairs, Regional teams, Pfizer laboratory assay groups, and external collaborators. The CS also plays a strategic role in partnership with Medical/Scientific Affairs to formulate operational plans and study strategies that align with Clinical Development and Life Cycle plans. The data produced from these epidemiological studies is vital for supporting clinical development, including planning for Phase 3 efficacy trials, determining incidence and risk groups, and fulfilling regulatory commitments for vaccine effectiveness studies.
KEY RESPONSIBILITIES
The CS for the RWE Platform in Primary and Specialty Care will lead multiple comprehensive epidemiological studies, adhering to various Standard Operating Procedures (SOPs) for each study, including: 1) protocol development, study design, and training, 2) data review and interpretation, 3) scientific oversight of studies and programs, 4) safety review and communication, 5) preparation and review of regulatory documents, study reports, and publications, and 6) oversight of clinical study implementation, with a strong emphasis on consistency, quality, data integrity, safety, and alignment with corporate values. Represents Clinical Affairs in program-wide functions, contributing to discussions that ensure consistency across all programs. May provide oversight for other RWE Platform Clinical Scientists within the program, reviewing their work, developing staff, and offering ongoing feedback. Responsible for resource planning, priority setting, and addressing resource and skill gaps. Utilizes expert knowledge of epidemiologic and observational study aspects to oversee operational strategic partner involvement at the program or study level, identifying issues promptly and leading the implementation of complex solutions. Influences management decisions and is recognized as the Subject Matter Expert on CS decisions affecting programs and Medical/Scientific Affairs groups. Collaborates with Medical/Scientific Leads and team members on epidemiologic and Phase IV study planning, contributing to annual Operating Plan and Lifecycle Plan development. Provides leadership in preparing regulatory submissions, responses to regulatory inquiries, and in readiness for program regulatory inspections and audits. Collaborates with Clinical Affairs and Medical/Scientific Leads to prepare strategic decisions and present data at relevant meetings. Represents TA Clinical Affairs and may lead company-wide global process improvement initiatives, advocating for enhancements and solutions to complex issues.QUALIFICATIONS
Candidates should demonstrate a range of leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and mentor others, and guide colleagues to achieve significant outcomes.
BA/BSc in life sciences or a 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, execution, and analysis. Significant experience leading operational and/or strategic study teams. Proven ability to work independently and collaborate with multiple functional groups. Experience in primary or specialty care is essential. Advanced capability in ensuring consistent medical/scientific concepts across multiple protocols to meet strategic program objectives. In-depth knowledge of the clinical research process and Good Clinical Practices from prior clinical research experience. Experience in authoring clinical protocols and other study documents. Proficient in statistics, data analysis, and interpretation. Experience managing external vendors for clinical and/or epidemiological studies. Fluent in English with exceptional written and oral communication skills.PREFERRED QUALIFICATIONS
MSc/MPH or PhD preferred. Experience in a global setting is advantageous. Proficiency in MS Office applications, including Teams, Word, Excel, and PowerPoint. Knowledge or experience in research for Specialty or Primary Care therapeutic areas is desirable. Previous industry experience is preferred.