Senior Clinical Research Scientist

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, 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.

This position is responsible for providing scientific leadership and expertise to clinical development programs. The 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, medical affairs, market access, 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

Strong background in data mining, literature searches, and scientific, 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
Remote / Field Based: General office or home office setting.

• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills
• Able to prioritize and operate proactively
• Must demonstrate critical thinking and proven problem-solving skills
• Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations
• Must be able to multitask

Physical Requirements:

• 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.

Employee that interacts with Healthcare Professional: In addition to below, Compliance with Cook Policy & Guidance On Interaction with Healthcare Professionals.
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.