Director, Clinical Pharmacology

Director, Clinical Pharmacology
Company:

(Confidential)


Director, Clinical Pharmacology

Details of the offer

Job Summary: The primary responsibilities of this position are to create the model:based drug development plan, design, conduct, and interpret Phase 1 studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK:PD and Pop PK:PD concepts and analysis, phase 1:4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug. This position effectively works independently for all phases of studies and participates in KOL and regulatory interactions at project level, and interacts with regional and global project team members, senior management, and outside vendors.
Responsibilities:

Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high:level supervision; participates in due diligence activities and represents global function on study and project teams

Produces independent writing for publications and regulatory documents

Serves as a specialist in PK:PD and Pop PK:PD concepts, phase 1:4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK:PD and Pop PK:PD analyses

Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management, and outside vendors; works independently for all phases of studies

Mentors direct reports and department; responsible for performance management and development of a limited number of employees

Responsible for all aspects of all studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high:level supervision; participates in due diligence activities and represents global function on study and project teams

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelors degree and Masters degree, PhD or PharmD

7+ years industry experience


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