Associate Director / Director Clinical Pharmacology
Core
Define and execute quantitative clinical pharmacology strategies for late-stage drug development, including PK/PD analysis, modeling, and regulatory interactions.
Role type
Director, Clinical Pharmacology
Builds
Clinical development plans and regulatory submissions for biopharmaceutical products
Domain
Biopharmaceuticals, Clinical Pharmacology, Translational Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD concepts, PK/PD modeling and simulation, regulatory submission preparation, clinical protocol design, biomarker strategy, health authority interaction, biologics and small molecules knowledge
Preferred skills
Experience with Phoenix or equivalent PK/PD software, matrix leadership, in-licensing and due-diligence evaluation
Technologies
Phoenix, PK/PD modeling software
Responsibilities
Oversee Model Based Drug Development (MBDD) application, contribute to clinical development plans, represent clinical pharmacology on project Core Teams, prepare regulatory documents for clinical pharmacology aspects
Seniority
Director, strategic leadership and cross-functional influence
