Director; Clinical Research-Respiratory Therapy Area

Job Summary Summary of Primary Responsibilities: Summary:The Associate Director/Director of Clinical Research reports to Senior Director, Clinical Research and provides medical input to all aspects of product development.Duties:- Deployed to the Symbicort team and emerging biologics team with focus on biological NCEs in respiratory and inflammatory diseases.- Serves as a source of medical expertise for product teams and provides input to decisions of the Therapy Area that may have medical and scientific and marketing implications relative to his/her expertise.- Responsible (in collaboration with other Product Team members) for the medical input to design, planning, initiation and completion of clinical trials of these and other compound early phase compounds.- Responsible for the preparation of medical components of Product Plans, the medical components of study protocols, IND, and other FDA communications under the direction of the Clinical Science Director.- Responsible to establish communications with prominent clinical investigators in his/her particular field of expertise, particularly those who will be willing and able to assist in the evaluation of AstraZenecas products in accordance with Product Team objectives.- Attends appropriate scientific meetings to maintain his/her awareness of research activities in his/her area of expertise.- Applies strategic intent of AstraZeneca when working with FDA, opinion leaders, prescribers and consumers of AstraZeneca products.- Performs product safety medical reviews for assigned investigational and marketed products as designated by the Clinical Science Director.- Provides medical and specialty expertise for safety surveillance of assigned AstraZeneca investigational products.- Ensures an appropriate level of customer service to internal and external customers.- Assumes other duties as assigned by the Clinical Science Director and Vice President, Medicine and Science Internal and External Contacts/Customers.- Works with Therapy Area management Team, Product Team Leadership, Product Strategy and Licensing groups responsible for creation of promotional materials to accomplish tasks and find ways to improve processes.- Works with internal and external customers, including Therapy Areas, Product Teams, PS&L, FDA-DDMAC to insure their satisfaction.




Responsibilities

Minimum Requirements:- Graduate of a recognized school of medicine with an M.D. degree or equivalent.- Specialty training and board certification or eligibility in Pulmonology or Allergy.- Familiarity with biostatistics.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally.Preferred Background:- Board certification in Pulmonology or Allergy.- Background in clinical research including biologicals - Scientific training such as a Ph.D. degree is desirable.- Two to three years experience in drug development/medical affairs (required for Director).- Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals (required for Director).- An understanding of US pharmaceutical safety reporting and surveillance (required for Director).