Director/senior Director Clinical Research- Respiratory
AstraZeneca (Delaware, Delaware)

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Summary of Primary Responsibilities: Summary: The Director of Clinical Research provides medical input to all aspects of product development.Duties:- Primarily deployed to the Symbicort team- Also deployed and to other teams such as the emerging biologics respiratory and inflammation teamsteam with focus on biological NCEs in respiratory and inflammatory diseases as determined by the Medical Science Section Director. Amount of time in this duty will be determined by level of experience chosen for the role.
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 Medical science section 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 Medical Science Sction 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 Medical Sience Section director and Vice President, Medical ence Internal and External Contacts/Customers.- Works with Therapy Area management Team, Product Team Leadership, Product team members responsible for creation of promotional materials 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, KOLs to insure their satisfaction.
Leadership Capabilities:
· Passion for Customers
· Thinks Strategically
· Acts Decisively
· Drives Performance
· Works Collaboratively
· Develops People & Organization

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/Immunology.- 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/Immunology.- Background in clinical research including biologicals and/or immunology- Additional scientific training such as a Ph.D. degree is desirable.- Two to three years experience in drug development/medical affairs (required for Director, beyond 5 years required for senior director).- Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals.- An understanding of US pharmaceutical safety reporting and surveillance.
Individuals with more experience may be considered for an Senior Director Director level role.