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Director, Clinical Sciences

Job Summary The Director, Clinical Sciences assists in the design, preparation, planning, implementation and review of clinical trials. This position ensures adherence to federal, state and AATB requirements and company and ethical standards. Responsibilities The specific duties of the Director include but are not limited to: o Serve as primary point of contact for assigned clinical studies. Authority and responsibility to approve all clinical study documentation, sub-contractors, internal processes/procedures and other clinical related activities o Participate in project team meetings and provides clinical representation o Participate in identification, evaluation and selection of clinical study sites and investigators o Develop or assist with development of study design, protocols, case report forms and other study-specific documents essential to appropriate implementation of clinical investigations o Work with investigators to ensure optimal compliance and performance to the protocol, regulatory requirements, discrepancy reporting and ethical practice. Assist with preparation and execution of Investigator meetings. o Ensure International Conference on Harmonization and Good Clinical Practice procedures are followed in all study aspects o Participate in vendor selection and establish plans for data processing and data review with vendors. Manage Clinical Project Managers and/or Clinical Research Associates. o Monitor clinical trials through all phases o Ensure clinical data integrity by performing investigator and on-site training and providing source documentation. Assist investigators by identifying issues, offering solutions and following to resolution o Read and critically interpret relevant literature. Serve as a resource for clinical knowledge o Ensure timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to complete study goals o Ensure timely, accurate collection of all adverse events, adverse reactions and complaint reports and implement follow-up actions o Present information and data at investigator and team meetings o Assist with preparation of Ethics Committee submissions and notifications/submissions to federal and state regulatory authorities o Obtain and review all Essential Study Documents necessary for study initiation and conduct o Draft or assist with drafting site and study budgets; participate in site negotiation and initiate site payments o Conduct site visits and reports. Conduct pre-study, initiation, interim and close-out visits and reports AxoGen (NASDAQ: AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. AxoGen's platform for peripheral nerve repair features a comprehensive portfolio of products which are available in the United States, Canada, the United Kingdom, and several other countries. We are building a culture that attracts, inspires, motivates, and develops individuals and teams to achieve excellence by embracing our values. We are just getting started, and we have a tremendous opportunity to improve the quality of life and offer hope for patients with debilitating nerve damage. We seek new team members who have AxoGenic values: Respect  o Demonstrates consideration for others' ideas and contributions.  o Engages in passionate debate around issues in a positive and constructive way with appropriate language.  o Communicates truthfully, completely and directly with the person or people involved.  Teamwork  o Consistently looks for ways to support all team members' success.  o Put's the whole team's/company's priorities ahead of individual priorities.  o Involves team members appropriately in decision-making and information-sharing.  Passion  o Willing to stand up for his/her beliefs and point of view.  o Consistently recognizes and focuses on the importance of the work we do, despite uncertainties and risk.  o Is optimistic and encouraging in words and actions.  Drive to Results  o Consistently anticipates and finds ways to overcome obstacles to achieving the goals  o Holds himself/herself accountable for taking tasks all the way to completion.  o Can clearly communicate important company goals and what he/she needs to do in order to accomplish them.  Customer Focus  o Considers the impact on the customer in every decision.  o Holds himself/herself to high standards of excellence to serve the customer.  o Is seen by the customer as highly responsive in every interaction. AxoGen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex. marital status, national origin, disability, or veteran status.  
Salary Range: NA
Minimum Qualification
Not Specified years

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