Associate Director/Director, Clinical Scientist
Location:
Gaithersburg , Maryland
Posted:
February 19, 2018
Reference:
R-016356
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  

We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Job Description: Clinical Scientist
Respiratory Syncytial Virus (RSV) infects all children by age 2 and it is a leading cause of doctor visits and hospitalizations throughout the world. There are no licensed vaccines or effective therapies. At MedImmune/AstraZeneca, we are developing a new biologic to protect children from pneumonia and bronchiolitis caused by RSV. Our lead molecule is entering late stage development and we are looking for a detail-oriented Clinical Scientist to join our experienced and hard-driving clinical development team. While experience in developing medicines for respiratory infections in infants would be beneficial, they are not required because of the depth of experience of the current team. This is an Associate Director/Director role and will report to a Senior Medical Director. The position is based in Gaithersburg Maryland.
Responsibilities
Under the supervision of a Senior Medical Director, serve as member of the cross-functional clinical trial team.
Key role in reviewing clinical study data and performing medical data review during study execution to ensure integrity of accruing study data including:
Assuring appropriate eCRF completion and logic checks
Compliance of enrollment with inclusion/exclusion criteria.
Monitoring of end-point data recorded in eCRF.
AE and Serious Adverse Events monitoring (in conjunction with Patient Safety and Medical Monitor).
Review of Physical Exam, Medical history and concomitant medication data.
Protocol Deviation review.
Coding reviews.
Table and Listing review.
Assist in preparing key product documents including:
Assist in the creation of the protocol summary sheet and the full protocol with support and input from other key team members such as the clinical development physician, Clinical Operations, Biostats, Translational, PK, and Regulatory
Assist in the development of key documents to support the components of regulatory submissions (i.e., clinical sections of INDs, IND Annual reports, IBs, Briefing book for pediatric implementation plan, responses to regulatory queries, IMPDs etc).
Provide Clinical Development input into the tactical execution of clinical protocols by collaborating with relevant functions e.g. Clinical Operations/ Biostats etc. Activities could include:
Interacting with project managers and CRAs from CROs
Participation in and organization of Investigator meetings and other scientific committees as required by the protocol (e.g. independent reviews, Data Safety Monitoring Boards, Steering Committees, etc.).
Study risk mitigation and highlighting of potential issues and solutions.
Assist in preparing publication of study results.
Participate in review and interpretation of results
Ensure study level activities are conducted to allow implementation of the study protocol in a manner consistent with the current plan/timeline and CDP
Requirement/Qualification
Education:
 PhD or Masters degree in clinical/health science field, PharmD, MD, or other advanced clinical degree (PA, NP, etc).
Experience:
2-6 years of progressive responsibility in clinical development
Experience in vaccine and infectious disease preferred
Experience in late-stage/Phase 3 preferred
Demonstrated ability to work in cross-functional teams and with individuals.
Demonstrated ability to develop and manage clinical research protocols
Demonstrated experience working with large clinical datasets
Skills/Ability:
Must have effective verbal and written communication skills and ability to relate to colleagues and associates at all levels both inside and outside the organization.
Supervision:
Role is of individual contributor. Must be able to operate independently in data review tasks under the supervision of Medical Monitor.
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 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.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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