Job Description:

Description:The Manager of Preclinical Research will serve as a key scientific contributor, subject matter expert (SME) and Manager in the execution of my clients' Preclinical Research Operations, including but not limited to in-vivo study design (Safety and EfficacyFunctionality 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.Job Responsibilities:The Manager of Preclinical Research will:Lead, staff, and manage their Preclinical Research TeamProvide 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, andor review study protocols and reports. Act as a technical mentor for the development of study experimental designs, protocols, and reports of junior associates.Administrate and manage their preclinical regulatory strategy and communication.Work with Contract Research Organizations (CROs) to execute both Biocompatibility Safety and EfficacyFunctionality 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 their core values. Be a Subject Matter Expert (SME) for 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 their 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 visionstrategy.Work with VP of Technology and Director of R&D to ensure long-term vision and goals met to reflect company's charter.REQUIREMENTSDVM, PhD or MD in relevant discipline required. Minimum 6+ years' experience in preclinical medical device research is required, preference given to veterinary 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 (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.Ability 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, regulatorynotified 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, GLPGMP, and ISO regulations is preferred.Hands-on research experience with hemostatic devices andor 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 out-sourced studies).BENEFITSCompetitive annual base salary range of $150,000 - $220,000, 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 WorkLife Employee Assistance Program 401(k) & Roth Retirement Savings Plan with company match up to 5% Monthly MetroCard Reimbursement