Clinical Research Scientist

1 month ago
Requisition ID
2017-3199
Job Location(s)
Pittsburgh PA United States
Travel
30-40%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Clinical

Overview

Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Clinical Research Scientist.  The Clinical Research Scientist plays an integral role in therapeutic program development at Cook MyoSite.  As part of a strategic team of medical science professionals who maintain both a regional and international presence, this position has significant responsibility and is expected to provide in-depth technical and scientific support to all clinical development programs. 

 

Responsibilities

• Provides technical and scientific guidance in the direction, planning, design, implementation, and interpretation of all phases of sponsored clinical trials and related data collection activities

• Works with cross functional teams (regulatory, business units, etc.) to evaluate new clinical projects and study strategy
• Participates in the preparation and review of study operational documents, plans, and training materials
• Works closely with project and study teams in regard to clinical data collection, investigator and site communications, and contributes to risk resolution by escalating and monitoring project risks
• Works across the full spectrum of analytical support of clinical trials from methods of data gathering to analyzing, reviewing, and interpreting results for subsequent preparation of formal assessments and recommendations for program development
• Develops plans for communicating a clear overview of study/program results to internal and external audiences, and engages in technical writing and review of presentations and other scientific communications
• Key stakeholder in development of clinical publication and communication strategies
• Provides broad medical and scientific support, including training and continuing education, to both internal and field-based teams
• Develops and maintains collaborative relationships with key experts, investigators and institutions strategic to areas of interest
• Participates in medical education and appropriate scientific exchange to enhance product and disease state knowledge
• Maintains knowledge as to developments and trends in applicable treatment landscape including current treatment strategies and new therapeutic developments

Qualifications

• Advanced degree in Life Sciences, Health Sciences, or Engineering required (PhD, MD, PharmD, DO preferred)
• A minimum of 3 years prior experience in the biotechnology or pharmaceutical industry serving in a professional clinical research capacity (subspecialty training or working knowledge in urology and/or gastroenterology preferred)
• Experience in the conduct and management of clinical studies
• Experience in writing study protocols and other technical documents
• Working knowledge of regulatory authority interactions, and clinical regulatory guidance and requirements
• Strong background in data mining, data analysis, literature review, and medical and/or regulatory writing
• Demonstrated ability to communicate effectively and confidently with experts and/or opinion leaders in applicable fields
• Strong team collaboration, leadership, communication (written and verbal), presentation, and issue identification and resolution skills
• Sufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic manner
• Ability to provide education on complex scientific/medical issues in a clear manner both peer and lay audiences

 

Physical Requirements:
• Willingness and ability to travel up to 40% of the time

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