Summary of Primary Responsibilities: The Director/Associate Director of Clinical Research reports to TA Clinical Director- Late Development and provides medical input to all aspects of product development. Duties:- Primarily deployed to an Established Brands Team but may also be deployed to teams supporting emerging respiratory and inflammation therapeutics as determined by the TACD and project Medical Science Directors. Responsibilities will be determined by level of experience.
Serves as a source of medical expertise for Therapy Area and product teams. 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 phase IIB, III, IIIB and Phase 4 clinical trials and study protocols.- Responsible for the preparation of medical components of Product Plans, IND and other FDA communications under the direction of the Medical Science Director .- Responsible for establishing communications with clinical investigators and thought leaders 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 Medical Science Director. -Provides medical and specialty expertise for safety surveillance of assigned AstraZeneca investigational products.- Works with Therapy Area management Team, Product Team Leadership, Product team members, and Product Strategy and Licensing groups responsible for creation of promotional materials and support of scientific and promotional communications.- Works with internal and external customers, including Therapy Areas, Product Teams, PS&L, FDA-DDMAC, KOLs to insure AZ development and commercial objectives are met. Ensures an appropriate level of customer service to internal and external customers.- Assumes other duties as assigned by the Medical Science Director and TA Clinical Director.
* Passion for Customers
* Thinks Strategically
* Acts Decisively
* Drives Performance
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. Demonstrated clinical research experience in an academia or industry.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally.
Preferred Background: Board eligibility/certification in Pulmonology or Allergy.- Background in clinical or basic science/translational research desirable. Two to three years experience in drug development/medical affairs (required for Director). Knowledge of CDER regulations regarding evaluation and approval of pharmaceuticals (regulatory interaction experience required for Director). An understanding of US pharmaceutical safety reporting and surveillance (required for Director).
Individuals with less experience may be considered for an Associate Director level role.
* Works Collaboratively
* Develops People & Organization
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