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AstraZeneca Pharmaceuticals LP
Director Clinical Research- Early Development Neuroscience TA
Location: Delaware,
Delaware
00000
Posted on:
7/17/2009 9:15:26 AM
Postion type:
Full time
Job Code:
1788251
Required Education:
Salary:
DESCRIPTION
Summary of Primary : The Associate/Director of Clinical Research reports to Group Director-Early Development Neurosciences Therapy Area and provides medical input to all aspects of product development.Duties:- Deployed to the Emerging Psychiatry team to support a mix of psychiatric and analgesia compounds including the development of appropriate clinical trials and endpoints leading to registration.- 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 Group 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 AstraZeneca's 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 Group 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 Group Director. 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. Leadership Capabilities:
· Passion for Customers
· Thinks Strategically
· Acts Decisively
· Drives Performance
· Works Collaboratively
· Develops People & Organization
REQUIREMENTS:
Minimum Requirements:- Graduate of a recognized school of medicine with an M.D. degree or equivalent.- Specialty training and board certification or eligibility in Psychiatry or Neurology.- Familiarity with biostatistics.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally.Preferred Background:- Board certification in Psychiatry or Neurology.- Scientific training such as a Ph.D. degree is desirable.- Three to five years experience in drug development/medical affairs (Director).- Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals (Director).- An understanding of US pharmaceutical safety reporting and surveillance.
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