My client is a public Pharmaceutical company located in RTP, NC
Director, Clinical Development
The Director, Clinical Development is responsible for all Clinical Development activities conducted by, or on the behalf of the company.
Principal responsibilities include:
Assisting the Head of Clinical & the Head Regulatory with the development of the corporate clinical strategy and the design, implementation, execution and submission/defense of clinical programs and their results which are intended to support regulatory and commercial commitments.
The Director will serve as a reviewer and final approval of clinical study protocols and participate in the review of data tables and study reports.
In addition, the Director is responsible for assuring that clinical data are vetted through most appropriate medium (abstracts, manuscripts, advisory boards, late breaking papers etc) and for presenting data to various audiences including the FDA, external thought leaders, and internal customers such as representatives from the Marketing & Sales organizations.
The Director will serve as a member of cross functional interdepartmental project teams as needed and serve as a clinical contact for FDA related matters. He/She will establish relationships with key thought-leaders in order to enhance therapeutic knowledge, as well as to be able to utilize these relationships to assist the organization with the clinical development activities.
Departmental responsibilities include supervising clinical department staff, assure that Clinical SOPs are current, or identify a plan for updating SOPs on a regular basis, identify training needs for new staff and provide feedback on performance for all Clinical staff at least once a year.
You must have a PhD or PharmD degree and a minimum of 8 years of experience in the pharmaceutical industry. Previous NDA or sNDA experience required as well as a thorough understanding of clinical operations. Previous direct experience with the FDA is required.
Personal characteristics for successful candidate include strong management, interpersonal, teamwork, and organizational skills.