Job: Director, Clinical Operations

Jobing Description

The Director is responsible for overseeing the conduct of global, pivotal, clinical trials and managing multiple trials over multiple indication programs and/or therapeutic areas in accordance with GCP regulatory requirements. A Director may coordinate the activities of multiple groups when the activities and goals of the groups overlap. The Director will participate in and provide suggestions for the strategic planning of Clinical Operations, to help shape cohesive Clinical Development Operations plans. Key Responsibilities: - Develops recommendations on policies and procedures for Clinical Operations -Establishes prowess integrating the activities of distinct functional groups across multiple projects - Possesses highly advanced knowledge of the Clinical Development process, including experience with IND and NDA submissions, as well as the equivalent European registration requirements - Oversees and manages direct reports in the conduct of all Clinical Operations duties to ensure work is completed accurately and in compliance with all regulatory requirements for US and other countries in a timely manner - Works closely with Medical Directors to make final selection of investigators and sites for clinical trials - Determines resource plans for program(s) ensuring appropriate staff, in-house or outsourced, available to meet program goals - Maintains the excellence of standards for preparation, organization and submission of all study files from the group - Plans strategically and anticipates problems and recommends process improvements to address current and future needs - Manages the development and maintenance of Clinical Operations SOPs, ensuring linkage with corporate and federal compliance policies in all related clinical trial conduct aspects, including GCPs and other applicable regulations - Provides coaching and performance management for team, ensuring coherent goals and priorities to support the program - Provides leadership across functional areas and clearly communicates objectives to the team - Prepares and delivers presentations to the most senior internal and external customers - May be responsible for the management of clinical trial drug products and processes for distribution to the site - May act as department head - Supervises other Clinical Operations staff as needed - Performs other duties as assigned Minimum Requirements: B.S. or Advanced Degree in a scientific or allied health field and 11 years of relevant work experience in the Biotech or Pharmaceutical Industry or relevant comparable backgroud. Must have Hepatitus C experience.