Director or Associate Director, Clinical Research, Emerging Oncology

Company: Major International Pharmaceutical Company

Location: Greater Philadelphia Region

Posting Date: 8/11/2008

 

Job Description:

Position Overview:

• Provides medical input to all aspects of product development Clinical Research.
• Responsible for early clinical trials – working with the Emerging Products brand team
• Serves as a source of medical expertise for product teams and provides input to decisions
• Responsible (in collaboration) for the medical input to design, planning, initiation and completion of clinical trials, 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
• Attends appropriate scientific meetings to maintain awareness of research activities in area of expertise.
• 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 investigational and products.
• Assumes other duties as assigned by the Clinical Science Director and Vice President, Clinical Research

Requirements:
Medical degree as a graduate of an accredited medical school.  Specialty training and Board Eligibility in Medical Oncology or related field.- Background in clinical research.- Familiarity with biostatistics.- Excellent written and oral communication, interpersonal, and organizational skills.- Ability to travel nationally and internationally. Preferred Background: - Board Certification in Medical Oncology or related field.

Director level - five years experience in drug development/medical affairs required. Thorough knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals (required for Director) Thorough understanding of US pharmaceutical safety reporting and surveillance.

Please send resume in confidence to Sandra@rjsearch.com