Director Clinical Pharmacology

The Director, Clinical Pharmacology actively contributes to multi-disciplinary teams by providing innovative and progressive thinking on projects and where appropriate, offers guidance to other team members.

In addition to possessing the scientific expertise, the incumbent must be capable of analyzing and interpreting study data and effectively communicating findings to a broad audience. The Director, Clinical Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to provide sound input on Clinical Pharmacology activities to a variety of project teams.

Essential Functions

· Directs and Implements clinical pharmacology plans and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)

· Leads the development of Clinical Protocols to meet CDP objectives.

· Serves as Study Director/Clinical Pharmacology Lead and drives the execution of the study from protocol concept to final report including interpretation of clinical data.

· Serves as Medical Monitor (where applicable) to review and monitor study data.

· Implements strategies to identify, monitor and resolve clinical program/trial issues.

· Interprets study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy.

· Contributes to Clinical Pharmacology expertise and content to regulatory documents (e.g. briefing books, INDs, NDAs etc.) and represent Clinical Pharmacology in discussions with Health Authorities.

· Reviews 3rd party work products and deliverables to approve payment of invoices and resolve discrepancies.

Requirements

· A PhD, MD or PharmD degree with at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead.

· A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational Medicine aspects of drug development.

· A thorough understanding of standard Clinical Pharmacology computational programs.

· Experience in oncology, pediatric development and translational medicine is preferred but not required.

· Strong inter-personal skills are required since the job requires substantial interaction within the assigned Business Group as well with other Pre-clinical, Modeling, and Translational Science Groups.

· Complies with all applicable laws/regulations of each country Clinet does business in.

· Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients or physicians.

· Minimal travel required: less than 10%