Director Clinical Research - Nexium/Lesogaberan

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Director Clinical Research - Nexium/Lesogaberan

Functional Area: Clinical Development

State: Delaware

City: Delaware

Other States: N/A

Field/Home based position: No

Search Band: Band 6

Department: Late Development CV/GI

Reporting to the Group Director- CV/GI TA Late Development, the GI Clinical Research/Brand Physician provides medical input to all aspects of product development, regulatory, and promotion across the entire product lifecycle as it applies to both NEXIUM and Lesogaberan. Approximately 50-75% of time for this position will be devoted to commercial and development related activities (U.S. and global brand activities) with the remainder devoted to project-related clinical research activities. Time will be equally divided between the NEXIUM and Lesogaberan. Key tasks include developing medical and commercial differentiation options for the brand versus the competition, review and sign off of publications and promotional material. The objectives will be set by the Group Director in agreement with the Medical Science Director and the Development Brand Leader.

Major Responsibilities
• Serves as a source of medical expertise and strategic oversight for the NEXIUM/Lesogaberan Brand Team
§ Provide medical expertise for Life Cycle Development and claims development.
• Provides medical guidance to NEXIUM/ Lesogaberan Brand Teams for creation of promotional and promotion-related training materials
• Give guidance to the NEXIUM Brand for Phase IV and investigator initiated trials in cooperation with regional marketing companies where applicable
• Responsible (in collaboration with other Team members) for medical components of study protocols, labeling and regulatory communications under the direction of the Medical 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 AstraZeneca’s products in accordance with Brand Team objectives
• Work with international colleagues on research initiatives and regulatory issues,
• Applies strategic intent of AstraZeneca when working with FDA, opinion leaders, specialty societies, prescribers and consumers of AstraZeneca products
• Assumes other duties as assigned by the Group Director
• Provides medical leadership and expertise for commercialization of the GI brands throughout their life cycle.
• Provides medical oversight into developing medical and commercial differentiation options for the brand versus the competition, review and sign off of publications and promotional material.

Organizational Behavior
1. Passion for Customer Solutions: Understands one’s customers and uses that insight to provide value

2. Thinks Strategically: Quickly identifies and acts on opportunities, combining forethought with action. This is based on an understanding of the external environment and its impact on AZ

3. Acts Decisively: Makes and acts on decisions quickly and effectively and fosters the same in others. This is based on an underlying courage to enable risk-taking for the business

4. Drives Performance: Holds self and others accountable for the achievement of performance expectations. Creates an environment that enables others to perform at their best

5. Works Collaboratively: Actively creates and promotes cross-boundary collaboration with the aim of achieving better business results. Boundaries can exist between individuals, geographies, cultures, teams, functions, organizations

6. Develops People and Organization: Demonstrates a genuine commitment to the time and effort needed to develop oneself and others

Works with internal and external customers, including Clinical Project Teams, Global Product Teams, Therapy Areas, Global Marketing and Business Development, Regulatory, and FDA to accomplish tasks related to the product development, to improve clinical development processes, and to insure satisfaction of these customers.

Reporting Relationship
If applicable, this section contains a list of positions that report to the position, either directly or indirectly
• Direct Reports –none
• Indirect Reports – none

Requirements – Education and Experience
• Graduate of a recognized school of medicine with an M.D. degree or equivalent.
• Specialty training and board certification in Internal Medicine or General Pediatrics and/or Gastroenterology
• Prior clinical experience and strong academic track record in gastrointestinal disease
• Three or more years of Drug Development experience obtained while working in the pharmaceutical industry with focus and expertise in gastrointestinal disease required for Director level position or equivalent strong Academic credentials with Industry related experience (Advisory Boards, Regulatory consultancy, participation in clinical trials, etc).
• Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including basic understanding of biostatistics and safety reporting
• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence those decision points
• An understanding of the interplay between clinical development and commercial objectives