Dir Clinical Research - ONGLYZA/ Dapagliflozin

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Dir Clinical Research - ONGLYZA/ Dapagliflozin

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

Clinical Research physicians are involved in the design, conduct, monitoring, data interpretation and reporting of clinical trials. These individuals must ensure that all clinical studies operate to the highest ethical and safety standards and in compliance with GCP and regulatory requirements. The physician provides medical and scientific expertise and tactical and strategic medical input to the discovery, development and/or commercialization of AZ compounds. The job-holder can expect to get broad global exposure to other functions involved in the R&D process within AZ, get an overview of how strategic direction is set within the clinical function and how decisions are made during a drug development.

In addition to working with the Clinical Development Team, some Brand related work may be combined with this role in support of the ONGLYZA and Dapaglifozin Commercial Brand Teams. This aspect of the role will function in partnership with the US Development Brand Leader (DBL) , the Global Brand Director, and the Medical Science Director (MSD). . The core responsibility is to provide medical leadership and expertise for commercialization of the brand throughout its life cycle. Key tasks include working closely with the DBL and/or the Global Brand Director to help develop medical and commercial differentiation options for the brand, as well as review and approval of publications and promotional material. Coverage of Global programs including South East Asia Region may be needed. Global travel might be required, approximately 25 % of time. This could vary according to program’s needs. Close interaction with the Medical Science Director about the overall medical aspects of the product strategy is also essential.

Depending on the CVGI Therapy needs at the time of hiring, the successful candidate will share his/her time between commercial related activities and development related. The objectives will be set by the Group Director in agreement between the Medical Science Director, Development Brand Leader and the Global Brand Director.

The principal responsibilities are summarized below:

Principal Responsibilities:
The general responsibilities are expected to vary according to the position level (Associate vs Director) with greater cross-functional interaction and through supervision of junior physicians if applicable. The number and scope of responsibilities is greater, dependent upon the exact role, as described below:
Clinical Development
(i) Contribute to the development of the Clinical Development Plan, as requested by the MSD
(ii) Assist the MSD in assessment of the overall benefit/risk of the product.
(iii) Prepare medical components of higher level documents (e.g. TPP, TPC, INDs, CTRs, NDAs/MAAs, labeling and other regulatory communications) under the direction of the MSD, as required.
(iv) Assist, and lead as required, investigator meetings
(v) Follow important developments and trends in the scientific literature and develop
contacts with opinion leaders.
(vi) Provide guidance in collaboration with other team members for creation of publications, promotional and promotion-related training materials
(vii) Assume other responsibilities under the direction of the CSD/Section Director and MSD.

Brand Team
• Medical content and ethical aspects of medical marketing and promotional activities
• Provide medical expertise for Life Cycle Development and claims development.
• Provide /take responsibility for medical aspects of core promotional material, promotional guide, monographs and symposia.
• Provide /take responsibility for medical aspects of publications and proactively identify new publication opportunities through analysis of data versus market needs.
• Development of key opinion leaders.
• Interacting with advisory boards.
• Give guidance for Phase IV and investigator initiated trials in cooperation with regional marketing companies.
• Medical input to competitor intelligence activities including critical review of competitor data.
• Medical contribution to marketing company briefings and PR programs
• Contribute to the Value Team.
• Input to medical disease area and product training as appropriate.

Works with internal and external customers, including Clinical Project Teams, US Brand 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
• Direct Reports –none
• Indirect Reports – none

Requirements – Education and Experience:

Given the breadth of different roles encompassed by the Director, Clinical Research role, it is recognised that some requirements may be more relevant to certain specific roles and therefore the following criteria are intended as guidance.
• Medical degree
• Board certified/eligible in relevant or related discipline(Internal Medicine, Endocrinology)
• Two or more years of Drug Development experience obtained while working in industry and/or academia

• Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including 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

Skills and Capabilities
Therapeutic area/general medical knowledge
Excellent communication, interpersonal, presentation and organizational skills
Attention to detail
Delivery focus

Organizational Behaviors
Integrity and high ethical standards
Excellent Team working skills
Ability to appreciate diversity and work as equals with global teams
Customer focused
Lead and participate in multicultural teams
Leadership in directing the work of others.

Leadership Capabilities:
1. Passion for Customers: 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 Organisation: Demonstrates a genuine commitment to the time and effort needed to develop oneself and others