Clinical Research Scientist 9/3/2016

Alkermes Waltham, MA

Company
Alkermes
Job Classification
Full Time
Company Ref #
6843
AJE Ref #
576079730
Location
Waltham, MA
Job Type
Regular

JOB DESCRIPTION

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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 www.alkermes.com .

Position Summary

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.

The CRS contributes to five key areas:





1 Ensures Quality Medical Science



* Using your background in human intervention research, develop clinical research study protocols

* Assist in determining subject inclusion/exclusion criteria, and research outcomes

* Select measures and appropriate data collection techniques

* Conduct research literature reviews



* Provides Clinical/Program Strategy



* Contribute to clinical development plans (research approach for moving drug from Phase 1 to Phase 3)

* Research new indications for a given molecule



* Assists with Regulatory Science



* Contribute to briefing documents (leadership role when appropriate)

* Add scientific rationale to FDA communications



* Contributes to Scientific Communication



* Stay current with competitor developments and major advances in disease field, and communicate intelligence to teams

* May contribute to scientific publications including posters, abstracts, and manuscripts.



* Serves as Internal Expert



* Support Scientific Advisory Boards

* Communicate with external experts, such as top researchers in the field

* Work cross-functionally with other groups (e.g. Preclinical Scientists, Regulatory Affairs, Business Development, and New Product Planning)



Minimum Education & Experience Requirements:





* An advanced degree (Ph.D.) in a related field

* Minimum 3 years of direct involvement with human intervention research

* A background in life sciences: psychology, neuropsychology, physiology, kinesiology, public health, epidemiology, or psychopharmacology

Knowledge/Skills Required





* Clinical study design, data collection, analysis, and data interpretation skills

* Experience interacting with clinical investigators and medical experts

* Excellent verbal, written, and interpersonal communication skills (fluency in English is required)

* Domestic travel (approximately 10

Desirable Knowledge/Skills:





* Background in CNS diseases such as (MS, depression, schizophrenia)

* Track record of publications with human experimental research (clinical trials, psychological, physical activity monitoring, physiological etc...)

* Knowledge of or experience in industry clinical research

* Knowledge of or experience with ICH, GCP and relevant regulatory requirements

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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