Preclinical Principal Scientist, Research & Development

Job Responsibilities

• 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
• Administer 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.

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, preference given to veterinary surgical or human surgical experience
• 4+ years of people management experience preferred
• Extensive knowledge of surgery, anatomy, toxicology, and pathology is required. Hands-on surgical experience 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
• Strong communication skills (both written and verbal) is required 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 is required
• Able to work effectively both independently and collaboratively in a dynamic team-oriented environment is required
• Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required
• Requires strong leadership and organizational skills including attention to detail and multi-tasking skills
• Able to understand and execute to project details but keep overall "big picture" view of projects, priorities, and strategies is required
• Medical Device product development experience, including knowledge of medical device regulations, 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) requirements, 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