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Clinical Director, Epidemiology and Research
2 months ago
Job Summary
Pfizer is seeking a highly experienced Clinical Director, Epidemiology and Research to lead the execution of clinical epidemiological studies and provide strategic oversight of core team activities. The successful candidate will have a strong background in epidemiology and research, with experience in leading operational and strategic study teams.
Key Responsibilities
- Lead the execution of clinical epidemiological studies, ensuring consistency of approach, conduct, and result reporting.
- Provide strategic oversight of core team activities, including epidemiology, biostatistics, clinical operations, and medical/scientific affairs.
- Collaborate with Scientific Affairs, Biostatistics, and Clinical Affairs teams to execute and project manage studies.
- Develop and implement complex solutions to issues arising during study execution, working with Clinical Affairs Lead, Clinical Epidemiologist/Medical/Scientific Affairs Lead, and partner representatives.
- 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.
- Contribute to discussions to ensure consistency across all programs, influencing management/senior management decisions, and being viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups.
- 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.
- Prepare regulatory submissions, responses to regulatory queries, and prepare for program regulatory inspections and audits, presenting and discussing data at relevant team, governance, external consultants, KOL, and potentially regulatory meetings.
Requirements
- Bachelor's or Master's degree in life sciences or health-related field, with 10+ years of practical experience, or Master's/PhD with 8+ years of experience, or PhD 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.
- 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.
