Clinical Trial Project Director- Global Medical Affairs

Gaithersburg, MD 20878

Posted: 11/02/2018 Industry: Other Area(s) Job Number: 32308

Clinical Trial Project Director- Global Medical Affairs

The Clinical Trial Project Director Global Medical Affairs (GMA) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on therapies and support our internal stakeholders with medical insight and expertise. GMA provides medical leadership with market participation and connectivity while also impacting the life cycle planning and execution of all our products. GMA aims to lead in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do. This role will be responsible and accountable for the operational planning, delivery, oversight and budget management of company sponsored studies and/or externally sponsored studies and/or Early Access Programs. The EDAD will work hand in hand with the scientific study leader who is responsible for all scientific aspects throughout all stages of the study (epidemiologist for observational studies, Medical Affairs Leader for interventional studies). In addition, this role will support MEOR’ s continuous improvement by developing expertise in a specific area of study delivery, serving as a point of contact for best practice, and contributing to the development and maintenance of guidance documents and training materials. The focus will be on one of the three main types of work as described below.

REQUIRED:

Bachelor’ s degree required preferably in medical or biological science or equivalent by experience. Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area.

Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools.

Scientific awareness and extensive knowledge of observational study guidelines and SOPs Extensive knowledge of early and late stage

Ability to effectively work with Clinical Research Organizations/External Providers. Proven ability to interact widely and effectively within the company across regions, functions and cultures.

  Experience and knowledge within compliant management of Externally Sponsored Scientific Research

Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment

  Open to periods of travel
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