Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Senior Clinical Research Scientist at Cook MyoSite, Inc. is responsible for providing scientific leadership and expertise to clinical development programs. The Senior Clinical Research Scientist will coordinate with cross-functional teams in the development of strategy, data analysis, and reporting for clinical studies/programs.
• Provides technical and scientific guidance for specific project or area of treatment or disease
• Works with cross functional teams (regulatory, business units, etc.) to evaluate new clinical projects and study strategy
• Develops clinical study designs and facilitates the transition of projects to clinical operations team
• Develops central trial documents and contributes to clinical development files
• Participates in the preparation and review of study-related plans, training materials, and regulatory updates
• Determines format, evaluation, and interpretation of clinical data
• Presents clinical trial data internally to relevant stakeholders
• Leads activities for disclosure of clinical trial data through clinical study reports, abstracts, slide and poster presentations, and manuscripts
• Key stakeholder in development of clinical publication and communication strategies
• Develops and maintains relationships with physician experts to ensure proper alignment of clinical development strategy
• Contributes to risk resolution by escalating and monitoring project risks
• Maintains effective communication with cross functional teams and stakeholders
• Performs literature reviews for area of treatment or disease
• Provides broad medical and scientific support, including training and continuing education, to both internal and field-based teams
• 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
• Master's degree in Life Sciences, Health Sciences, or Engineering and 2 years of direct, relevant biotech/pharma industry clinical research experience
• PhD in Life Sciences, Health Sciences, or Engineering is preferred
• Strong background in data mining, literature searches, and medical and/or regulatory writing
• Experience in the conduct and management of clinical studies;
• Experience in writing study protocols and other technical documents;
• Working knowledge of regulatory authorities and other regulatory requirements
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Proficiency or comfort level working with material of a highly technical or scientific nature.
• Full time remote position | Flexible work environment
• Setting (Remote/Field Based): General office or home office setting
• Travel: 10-20%
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment
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