Director Quantitative Pharmacology
Core
Lead quantitative pharmacology analyses and regulatory strategy for R&D programs, ensuring high-quality PK/PD evaluation and regulatory submissions.
Role type
Director, Quantitative Pharmacology (Pharmacometrics)
Builds
Regulatory briefing books, CTD summaries, and quantitative analysis reports for BLA approvals
Domain
Pharmaceutical drug development, Pharmacometrics, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD evaluation, regulatory strategy development, regulatory agency interaction, advanced drug development knowledge, scientific literature analysis, quantitative tools usage, report development, functional review processes
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage PK/PD evaluation of product portfolios, inform management of regulatory developments, ensure analysis accuracy and documentation quality, develop meaningful storylines for reports, conduct functional reviews of study reports, author regulatory briefing books and CTD summaries
Seniority
Director, strategic leadership with hands-on technical expertise
