Peregrine Pharmaceuticals, on the list of Deloitte & Touche’s 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on clinical research management expertise and pharmaceutical industry experience to become part of our successful team. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab which has been given a fast-track designation by the FDA.
The Director/Sr. Director, Clinical Research oversees the direction, planning, execution, and interpretation of clinical trials research and clinical operations. This role establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. The ideal candidate will have proven experience leading new and ongoing clinical research and clinical trials to ensure efficient and timely processing of confidentiality and clinical agreements. This key role interacts with investigational sites, clinical consultants, Contract Research Organizations and other vendors. We seek a dynamic experienced clinical team builder with strong abilities to select, develop, mentor and evaluate clinical personnel to ensure the successful and efficient operation of the department.
ESSENTIAL DUTIES AND RESPONSIBILITIES
•Oversees and manages clinical development including the efficient planning and execution of clinical trials within established budget and timelines assuring all activities are in compliance with appropriate regulation.
•Optimizes tactical and clinical value through global site selection.
•Oversees adherence to protocols and determines study completion.
•Directs internal and external resources to ensure timely patient recruitment, trial site selection, trial plan optimization and execution of quality trials.
•Leads, manages and directly supervises employees in the Clinical Affairs department.
•Responsible for interviewing, hiring, training and performance evaluation of employees.
•Plans, assigns and directs the work of employees.
•Oversees the development and implementation of SOP’s for clinical research including SOP’s for clinical trials and related activities.
•Manages the clinical department budget and ensures the overall operation is within budget and timelines are agreed to in annual strategic goal setting.
•Communicates regular updates to the management team on progress against timelines and budgets in support of all clinical projects.
•Must be available to travel up to 30% domestically and internationally.
A Master's degree, MD or PhD in the life sciences is preferred. We require a minimum of 12 years of pharmaceutical industry experience to include significant clinical research leadership roles. Extensive background in direct management, development and supervision of a clinical operations team is required. Oncology clinical trials experience is highly desirable.
Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Peregrine Pharmaceuticals and Avid Bioservices do not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran.