Endocrinology Clinical Research Physician

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Matthew Masterson
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Endocrinology Clinical Research Physician

 Gaithersburg, MD

Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines

Endocrinology Clinical Research Physician CVMD Global Medicines Development

Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.
Description/Role Purpose:
The Endocrinology Physician provides medical input to all aspects of product development, for new and innovative treatments being developed in patients with diabetes. The majority of time will be devoted to Phase III project related clinical research activities including clinical activities in support of regulatory approval and market access. The remainder may be devoted to Life Cycle Management (LCM) and development related activities. The objectives will be set by the Group Director in agreement with the Medical Science Director.
Major Responsibilities
? Provide medical/scientific expertise for Phase III and/or LCM activities to support claims development in accordance with the agreed Target Product Profile (TPP)
? Responsible for medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other team members) labelling and regulatory communications under the direction of the Medical Science Director or delegate
? Ensures that study design is scientifically robust, suitable to test the trial's hypothesis, and likely to meet the objectives of the trial
? Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and local practices as applicable
? Responsible (in collaboration with other team members) for integrating payer evidence into clinical development programs to support market access and reimbursement
? Responsible to establish and maintain communications with prominent clinical investigators in his/her particular field of expertise
* Work with international colleagues and with external Alliance partners on research initiatives and regulatory issues
* Applies strategic intent of AstraZeneca when working with Alliance partners, FDA, payers, opinion leaders, prescribers and consumers of AstraZeneca products
* May serve as a source of medical expertise for the Product Brand Team
* May provide guidance for Phase IV and investigator initiated trials in cooperation with regional marketing companies
* Assumes other duties as assigned by the Group Director
Major Accountabilities
* Accountable to the Medical Science Director or delegate for the design, medical/scientific aspects of execution, and clinical interpretation of Phase III or LCM studies
* Accountable for aligned strategies supporting clinical trials and commercial value that improve compound risk profiles at investment decisions
* Accountable to MSD (or delegate) and GMed leadership for identifying risks to successful execution of Phase III or LCM studies and proposing mitigation strategies
* Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws

Requirements: 
Requirements -- Education and Experience
* Graduate of a recognized school of medicine with an M.D. degree or equivalent.
* Specialty training and board certification in Endocrinology or Internal Medicine
* Clinical experience and strong academic track record in Diabetes
* Experience in designing, monitoring and implementing clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting
* Demonstrated leadership qualities, capable of conducting a large study as part of a global team
* Functions within a matrix environment, contributes to decision-making and reaching alignment in order to meet challenging timelines
* Works collaboratively, respects other working cultures, including Alliance and Academic partners
* Good presentation skills. Can communicate effectively with internal stakeholders as well as external partners and collaborators
* 5 or more years of Drug Development experience obtained while working in the pharmaceutical industry and/or substantial clinical trial experience collaborating with pharmaceutical sponsors
* 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, LCM, commercial objectives and regulatory requirements
Organizational Behavior
1. Commitment to Customers and Integrity: Understands one's customers and uses that insight to provide value
2. Strategic Leadership: 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 Accountability: 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
Customers:
Works with internal and external customers, including Clinical Project Teams, Global Product Teams, Therapy Areas, Global Marketing and Business Development, AstraZeneca Regulatory, External Alliance Partners, Regulatory Authorities (e.g EMA, FDA), and Payer Boards to accomplish tasks related to clinical product development and achievement of market access ensuring satisfaction of these customers.

- Apply online at: http://www.hirelifescience.com/seeker_jobs.aspx?jobsID=456767&jobtitle=Endocrinology%20Clinical%20Research%20Physician