Director, Clinical Pharmacology (Immunology)
Core
Leads Clinical Pharmacology/PK/PD activities and multiple major projects, providing scientific and strategic consultation to R&D and regulatory agencies to support drug development objectives.
Role type
Director, Clinical Pharmacology (Immunology)
Builds
Drug development pipelines and regulatory submissions for immunology and other therapeutic areas
Domain
Biopharmaceuticals / Clinical Pharmacology / Pharmacometrics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
PK/PD modeling and simulation, Pharmacometrics, Drug metabolism/Transporters, Clinical protocol review, Regulatory document writing, Risk assessment, Project management, Cross-functional leadership, Strategic planning
Preferred skills
Experience across range of development phases, Knowledge of AbbVie drug development processes, Process improvement initiatives, Mentoring and team development
Technologies
PK/PD data analysis software, Modeling and simulation tools
Responsibilities
Leads Clinical Pharmacology/PK/PD activities and multiple major projects; Conducts risk assessments and develops contingency plans; Negotiates project outcomes and deliverables with functional areas; Provides scientific and strategic consultation on critical decisions; Evaluates technical aspects of projects and reviews clinical protocols for regulatory filings; Represents the department on business development teams; Identifies and develops process improvement initiatives; Influences strategic PK/PD decisions for the department.
Seniority
Director, strategic leadership with hands-on scientific expertise