Clinical Scientist - Gaithersburg, MD | Biospace
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Clinical Scientist

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/20/2017
Position Type:
Full time
Job Code:
R-009077
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
Maryland,
United States
Job reference: R-009077

Posted date: Aug. 09, 2017



At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Clinical Scientist in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

AstraZeneca leverages strength and expertise in Immunology Science, where research efforts are focused on gaining a better understanding of the common biology and shared molecular pathways among inflammatory and autoimmune diseases, as well as the fundamental drivers and mechanisms of disease. This approach enables us to identify and select drug targets that have the potential to effectively treat not just one, but multiple inflammatory and autoimmune diseases.

Main Duties and Responsibilities:

As the Clinical Scientist you will assist in clinical development activities which include the preparation of Clinical Development Plans (CDPs), investigational brochures, protocols, Clinical Study Reports (CSRs), pharmacovigilance activities and any aspect that contributes to the development and execution of clinical trials as well as regulatory submission activities. You may serve in various roles including membership on a clinical team and clinical project sub-teams and may serve in leadership roles within these teams. Your objectives as the Clinical Scientist will be set by the Group Director in agreement with the Global Clinical Lead (GCL). You will have a special focus on clinical trials within the Inflammation, Autoimmunity and Neuroscience Therapeutic Area (TA) where you Clinical Scientist will work in close collaboration with the Study physician and or Medical Director(s)/Global Clinical Leader (GCL).

You will collaborate with Contract Research Organization (CRO) functional area leads for outsourced studies to contribute to clinical trials execution. You will help drive study set-up with special focus on ensuring high quality data collection in the Web Based Data Capture system in line with the study protocol. You will be responsible for working with the Study Physician(s) on the medical monitoring of the clinical trials. You will support Clinical Submission teams with global submission and approval activities including reviewing of data, crafting of documents, responding to Health Authority questions. You will represent AstraZeneca in interactions with external scientific consultant and may organize meetings with the external scientific consultants that are either program or study specific (i.e. advisory board meetings, steering committee meetings, etc.).

Requirements

Essential Requirements:

  • Bachelor’s degree/Master’s degree in a health science field.
  • Relevant clinical research experience with at least one to five years of experience.
  • Thorough understanding of cross-functional clinical processes, including GCP and Safety.
  • Immunology experience.
  • Strong oral and written communication skills.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.