Chief Scientific Officer (CSO)
FibroBiologics is a regenerative medicine company developing an innovative cure for chronic diseases using fibroblasts. There are only two cell types in the human body which can regenerate tissue and organs. Those cells are stem cells and fibroblasts. Research has proven that fibroblasts are more effective and more potent than stem cells in the regeneration of tissue and reduction in inflammation.
Fibroblasts comprise the main cell type of connective tissue, possessing a spindle-shaped morphology, whose classical function has historically been believed to produce extracellular matrix responsible for maintaining structural integrity of tissue. Fibroblasts also play an important role in proliferative phase of wound healing, resulting in deposition of extracellular matrix.
FibroBiologics holds 150+ U.S. and international issued patents issued/pending across a variety of clinical pathways, including Disc Degeneration, Cancer, and Multiple Sclerosis. FibroBiologics represents the next generation of medical advancement in cell therapy. FibroBiologics is transitioning into a publicly-traded company.
The Chief Scientific Officer is responsible for providing strategic, managerial and scientific oversight of all research activities. This individual will develop and manage the Company’s entire Clinical Research function including identifying, selecting, guiding, and managing external research partners. In addition, this individual will contribute to overall study design, ensuring that effective, operationalizable clinical protocols are developed. In doing so, this individual will also be working closely with colleagues from Clinical Development, Regulatory Affairs, and other disciplines. The Chief Scientific Officer will build and lead an science focused and efficient Clinical Research organization.
- Ensure that resources, personnel and expertise are appropriately prioritized and deployed to successfully and efficiently meet researc timelines and budgets.
- Develop and execute global research strategies in close collaboration with internal stakeholders, Clinical Research Partners and other external partners.
- Ensure that vigorous scientific methods are used in furtherance of disease specific research goals.
- Adopt and implement agreed new methodologies and technologies in clinical research.
- Continue and promote the culture of operating effectively and efficiently.
- Provide technical and strategic expertise to ensure consistent processes, excellence in planning and execution of clinical research within agreed timelines.
- Develop and manage the clinical research budget with a focus cost effectiveness, efficiency and quality.
- Ensure internal and external communications & transparency.
- Set clear standards and expectations for the accurate and timely execution of clinical research and the operations teams that support them.
- Communicate regularly and effectively with all clinical operations team members and other internal and external stakeholders.
- Promote collaborative relations with stakeholders, vendors, consultants, and external clinical research partners.
- Research and regularly present innovative clinical research strategies, risk mitigation tactics and post study lessons and assessments.
- A highly developed understanding of complex clinical research design and execution across all phases of clinical development with a minimum of 10 years of progressively increasing roles in clinical research management.
- Thorough working knowledge and understanding of Good Clinical Practices and ICH Guidelines and other applicable international regulations.
- Demonstrated scientific and operational acumen with the ability to influence senior leaders and stakeholders in terms of clinical research design and development strategy.
- Record of successfully completed clinical research programs in all phases and multiple therapeutic areas as well as extensive CSO oversight experience.
- Ability to provide motivational leadership to the organization and improve its performance through the adoption of novel approaches to clinical operations management.
- A record of active leadership in the preparation of regulatory submissions.
- Inherent drive to cultivate collaboration, teamwork, and professionalism.
- Patient Focus: adopting patient perspective in all interactions.
- Ability to work independently, be an effective leader, and an engaged team member in a dynamic, fast-paced, and lean environment.
- Nimble, creative, entrepreneurial with the ability to independently execute.
- Motivated to learn or advance own expertise and value.
- Systemically organizing and completing detailed tasks, checking accuracy and completeness of information.
- Highly attentive to detail and focused on quality.
- Results oriented and able to multi-task.
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