Temp - Director Pharmacoepidemiology
Core
Develop and implement pharmacoepidemiology strategy for real-world evidence (RWE) and regulatory agency-required epidemiologic studies to support clinical development and regulatory filings.
Role type
Director, Pharmacoepidemiology
Builds
Real-world evidence studies, risk management plans, benefit-risk analyses, and regulatory submissions
Domain
Biopharmaceuticals / Clinical Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacoepidemiology strategy, Real-world evidence (RWE) generation, Regulatory agency study design, Risk management planning, Benefit-risk analysis, Signal management, Database management (claims/EMR/registries), Cross-functional team leadership, Vendor/contractor management, SOP development
Preferred skills
Strategic partnership development, Process improvement, Financial management acumen
Technologies
None explicitly listed
Responsibilities
Lead cross-functional project teams for epidemiologic studies; Design and implement studies for post-marketing commitments; Contribute to Risk Management Plans and Benefit-Risk analyses; Manage external vendors and contractors; Develop and maintain professional relationships with external experts; Drive process improvement initiatives
Seniority
Director, strategic leadership
