Cresilon, Inc.
Preclinical Principal Scientist, Research & Development
Cresilon, Inc., New York, New York, us, 10261
Overview
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. 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 technical mentor for the development of study experimental designs, protocols, and reports of junior associates. Administrate and manage Cresilon 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 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 preclinical research department growth strategy. Interact with the internal and external scientific community to maintain state of the art knowledge. Oversee the development and modification of preclinical models to address project needs. Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines. Survey the literature to identify and compare competitive product performance and safety risks. Maintain current knowledge in existing regulations, requirements and standards, including global regulatory requirements (ISO, FDA) and compliance requirements (GLP, USDA, AAALAC, SOPs, policies). Collaborate 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. Interface regularly with management to ensure research operations reflect the corporate vision/strategy. Work with VP of Technology and Director of R&D to ensure long-term vision and goals are met to reflect the company’s charter. Requirements
DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required. Minimum 6+ years’ experience in preclinical medical device research is required, with preference for veterinary or human surgical experience. 4+ years of people management experience preferred. Extensive knowledge of surgery, anatomy, toxicology, and pathology is required. Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred. Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred. Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations. Experience with surgical publication submission strategy is strongly preferred. Strong communication skills (written and verbal) with the ability to extract key facts from complex information and present concise summaries to management. Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred. Excellent problem solving, conflict resolution, and analytical skills are required. Ability to work effectively both independently and collaboratively in a dynamic, team-oriented environment is required. Prior experience working with external CROs and collaborators with professionalism and discretion is required. Strong leadership and organizational skills including attention to detail and multi-tasking. Able to understand project details while maintaining a big-picture view of priorities and strategies. Medical Device product development experience, including knowledge of medical device regulations and regulatory/notified body requirements is preferred. Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP). Experience in developing and commercializing regulated devices under Design Control (21 CFR 820), GLP/GMP, and ISO regulations is preferred. Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred. Legal authorization to work in the United States. This position is located in Brooklyn, NY and may require up to 30% travel to monitor and execute outsourced studies. Equal Opportunity
Cresilon is an equal-opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits
Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications. Paid Vacation, Sick, & Holidays Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage Company Paid Life and Short-Term Disability Coverage Work/Life Employee Assistance Program Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5%
#J-18808-Ljbffr
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. 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 technical mentor for the development of study experimental designs, protocols, and reports of junior associates. Administrate and manage Cresilon 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 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 preclinical research department growth strategy. Interact with the internal and external scientific community to maintain state of the art knowledge. Oversee the development and modification of preclinical models to address project needs. Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines. Survey the literature to identify and compare competitive product performance and safety risks. Maintain current knowledge in existing regulations, requirements and standards, including global regulatory requirements (ISO, FDA) and compliance requirements (GLP, USDA, AAALAC, SOPs, policies). Collaborate 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. Interface regularly with management to ensure research operations reflect the corporate vision/strategy. Work with VP of Technology and Director of R&D to ensure long-term vision and goals are met to reflect the company’s charter. Requirements
DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required. Minimum 6+ years’ experience in preclinical medical device research is required, with preference for veterinary or human surgical experience. 4+ years of people management experience preferred. Extensive knowledge of surgery, anatomy, toxicology, and pathology is required. Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred. Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred. Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations. Experience with surgical publication submission strategy is strongly preferred. Strong communication skills (written and verbal) with the ability to extract key facts from complex information and present concise summaries to management. Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred. Excellent problem solving, conflict resolution, and analytical skills are required. Ability to work effectively both independently and collaboratively in a dynamic, team-oriented environment is required. Prior experience working with external CROs and collaborators with professionalism and discretion is required. Strong leadership and organizational skills including attention to detail and multi-tasking. Able to understand project details while maintaining a big-picture view of priorities and strategies. Medical Device product development experience, including knowledge of medical device regulations and regulatory/notified body requirements is preferred. Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP). Experience in developing and commercializing regulated devices under Design Control (21 CFR 820), GLP/GMP, and ISO regulations is preferred. Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred. Legal authorization to work in the United States. This position is located in Brooklyn, NY and may require up to 30% travel to monitor and execute outsourced studies. Equal Opportunity
Cresilon is an equal-opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits
Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications. Paid Vacation, Sick, & Holidays Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage Company Paid Life and Short-Term Disability Coverage Work/Life Employee Assistance Program Monthly MetroCard Reimbursement 401(k) & Roth Retirement Savings Plan with company match up to 5%
#J-18808-Ljbffr