Senior Director, Clinical Pharmacology
Core
Lead clinical pharmacology strategy and studies for early-stage drug development, supporting translational programs and regulatory submissions.
Role type
Senior Director, Clinical Pharmacology
Builds
Clinical pharmacology studies, regulatory documents (INDs, NDAs/BLAs), and exposure-response analyses for new medicines.
Domain
Biopharmaceuticals / Clinical Pharmacology / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology strategy, PK/PD modeling, PBPK modeling, regulatory strategy, due diligence, cross-functional leadership, resource management, scientific communication
Preferred skills
NONMEM, Monolix, Simcyp, GastroPlus, population PK modeling, drug-drug interaction assessment
Technologies
NONMEM, Monolix, Simcyp, GastroPlus
Responsibilities
Develop clinical pharmacology strategy consistent with target product profile; define biopharmaceutics and clinical pharmacology studies for NDA support; lead clinical pharmacology activities for early-stage programs; design and oversee execution of PK/PD studies including ADME and DDI; determine scope and analyze Phase 1-IV studies; contribute expertise to due diligence for in-licensing; serve as primary Clin Pharm lead in cross-functional teams; provide scientific leadership with regulatory agencies; prepare Clinical Pharmacology sections of regulatory documents; manage resources, timelines, and budget.
Seniority
Senior Director, strategic leadership & team management
