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Senior Clinical Manager, R&D

HUVEPHARMA, INC

The Senior Clinical Manager of R&D is responsible for proactively designing, planning and executing independent clinical activities that support R&D research and development project across all species. This position leads and manages the activities of the Clinical R&D team based in Lincoln NE. Education and Experience Bachelor’s degree in a relevant scientific field (Biology, Microbiology, Molecular Biology, Biochemistry, or related) with a minimum of 15 years relevant Industry experience. Master’s degree in a relevant scientific field with a minimum of 10 years industry experience. PhD in a relevant scientific field with a minimum of 5 years industry experience. DVM preferred. Must have demonstrated experience leading and managing projects and clinical activities within the AH industry in several different species. Swine experience is a must. Must have demonstrated relevant experience leading and managing people within the AH industry Technical Skills Requirements Strong leadership skills, especially influencing and leading across functions and performance management, in a high paced environment. Ability to think strategically while aligning and managing details at a tactical level. Experience training and developing scientists at different levels. Demonstrated ability to work effectively and communicate effectively with departments outside R&D eg. regulatory, manufacturing, quality. Excellent verbal and written communication skills with both internal and external clients. Ability and experience delivering project updates to senior leadership. Demonstrated proficiency writing protocols and reports for submission to regulatory agencies such as CVB. Thorough understanding of working with CVB and the US requirements for licensure. Knowledge and ability to analyze complex data and make good business decisions based on this analysis. Ability and experience to lead a project, or function as a project subject matter expert and capable of managing multiple projects at the same time. Adept at conflict resolution and building bridges to achieve the goals and objectives of the company. Physical Requirements The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the job i.e. routine office and lab work. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be sitting for long periods of time. Some travel will be required (up to 30%). Position Responsibilities Assumes leadership of the clinical activities of R&D Biologicals across all species, effectively utilizing the internal clinical resources in Lincoln to deliver on projects and timelines. Works closely with the Regulatory team and department leaders to develop project plans and strategic plans for future research and development projects. Manages contract research organizations to develop study protocols, conduct studies and prepare reports that are acceptable to USDA-CVB. Leads and manages the Clinical team members based in Lincoln. Ensures resources are effectively utilized, performance management and development of team members. Prioritizes study conduct per R&D project priorities. Effectively leads projects and works with external collaborators to achieve project goals and objectives. Works with Senior leaders to bring new research ideas and projects into the company. Establishes and develops relationships with external parties that may result in new pipeline ideas and projects for the company. Evaluates patent applications, manuscripts for publication and due diligence activities as needed. Works with Regulatory pharma team and supports pharma clinical activities, when needed. #J-18808-Ljbffr

Vacancy posted 20 hours ago
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