Preclinical Principal Scientist, Research & Development

Cresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.

The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME), and Project Manager in the execution of Cresilon's Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project's product for domestic and international regulatory and clinical acceptance. This position is a hybrid role, with work off-site at CRO in the NY area, work from home, and on-site at Brooklyn NY.

Job Responsibilities:

The Preclinical Research Scientist will:

• Lead, staff, and manage Cresilon's Preclinical Research activities.
• Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life-cycle.
• Plan, direct, coordinate, and execute activities related to the design, initiation. and follow-up of studies to support approval of Class I-III medical devices.
• Develop, write, and/or review study protocols and reports. Act as a technical mentor for the development of study experimental designs, protocols, and reports of junior associates.
• Administrater and manage Cresilon's preclinical regulatory strategy and communication.
• Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites.
• Ensure that the company operates within the scope of regulatory compliance, including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon.
• Be a Subject Matter Expert (SME) for the preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state-of-the-art knowledge.
• Oversee the development of and modifications to preclinical models to address project needs.
• Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines.
• Surveys the literature to identify and compare competitive product performance and safety risks.
• Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc)
• Work cross-functionally with Regulatory and Quality to assess project risks, product safety, and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary.
• Manage budgetary requirements for all research projects to support efficacy and safety programs.
• Lead the effort to publish surgical research in peer-reviewed journals.
• Regularly interface with management to ensure research operations reflect overall corporate vision/strategy.
• Work with the VP of Technology and the Director of R&D to ensure long-term vision and goals are met to reflect the company's charter.nd