Director, Clinical Pharmacology
Core
Leads Clinical Pharmacology/PK/PD activities, manages major drug development projects, and serves as a strategic liaison between R&D, regulatory agencies, and executive management.
Role type
Director, Clinical Pharmacology (Strategic Leadership & Hands-on IC)
Builds
Drug development pipelines, regulatory submissions, and strategic PK/PD plans for AbbVie's therapeutic areas.
Domain
Pharmaceutical industry, Drug Development, Clinical Pharmacology, Pharmacometrics (PK/PD/PBPK)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> research (drug development data interpretation, protocol review, regulatory filings)
Required skills
Clinical Pharmacology expertise, Pharmacometrics (PK/PD/PBPK), Drug metabolism/Transporters knowledge, Strategic planning, Risk assessment, Regulatory document writing, Cross-functional negotiation, Team leadership, Project management, Scientific consultation
Preferred skills
Experience across multiple therapeutic areas, Knowledge of AbbVie drug development processes, Process improvement initiatives, Mentoring capabilities
Technologies
PK/PD data analysis software, Modeling and simulation tools
Responsibilities
Lead Clinical Pharmacology/PK/PD activities and multiple major projects; Conduct risk assessments and develop contingency plans; Provide scientific and strategic consultation to R&D and Regulatory teams; Review clinical protocols and scientific reports for regulatory filings; Lead regulatory document writing and submission; Manage personnel including development and mentoring; Identify and develop process improvement initiatives.
Seniority
Director, Strategic Leadership with hands-on technical execution