Clinical Research Scientist

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POST DATE 9/11/2016
END DATE 1/16/2017

Alkermes Waltham, MA

Waltham, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


td p span span Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at  /span /span a href="" span span span /span /span /span /a span span . /span /span /p p strong span span Position Summary /span /span /strong /p p span span We are currently seeking a Clinical Research Scientist (CRS) to join our Clinical Science Department. This position will report to the Senior Clinical Research Scientist, and will support the Medical Directors, and other Clinical Development colleagues in the delivery of company objectives.  The CRS will also partner with the clinical operations team to ensure study delivery. /span /span /p p span span The CRS contributes to five key areas: /span /span /p ol li strong span span Ensures Quality Medical Science /span /span /strong ul li span span Using your background in human intervention research, develop clinical research study protocols /span /span /li li span span Assist in determining subject inclusion/exclusion criteria, and research outcomes /span /span /li li span span Select measures and appropriate data collection techniques /span /span /li li span span Conduct research literature reviews /span /span /li /ul /li li strong span span Provides Clinical/Program Strategy /span /span /strong ul li span span Contribute to clinical development plans (research approach for moving drug from Phase 1 to Phase 3) /span /span /li li span span Research new indications for a given molecule span span span span span span span span ​ span span span span span span ​ /span /span /span /span /span /span /span /span /span /span /span /span /span /span /span /span /li /ul /li li strong span span Assists with Regulatory Science /span /span /strong ul li span span Contribute to briefing documents (leadership role when appropriate) /span /span /li li span span Add scientific rationale to FDA communications /span /span /li /ul /li li strong span span Contributes to Scientific Communication /span /span /strong ul li span span Stay current with competitor developments and major advances in disease field, and communicate intelligence to teams /span /span /li li span span May contribute to scientific publications /span /span span span including posters, abstracts, and manuscripts.  /span /span /li /ul /li li strong span span Serves as Internal Expert /span /span /strong ul li span span Support Scientific Advisory Boards /span /span /li li span span Communicate with external experts, such as top researchers in the field /span /span /li li span span Work cross-functionally with other groups (e.g. Preclinical Scientists, Regulatory Affairs, Business Development, and New Product Planning) /span /span /li /ul /li /ol