Aziyo currently has post market clinical programs in a number of therapeutic areas including cardiovascular and orthopedics in support of the Company’s overall goals. The Director of Clinical Operations will be responsible for all clinical activities from the design of studies through data collection and close out of clinical sites. This may also include the analysis and interpretation of clinical data. This individual will also develop data collection tools, perform data review and analysis, and be responsible for the completion and oversight of site assessment and initiation activities.
Position reports to the Vice President, Clinical Development.
Essential Duties & Responsibilities
• Provide oversight of operation of all Aziyo clinical programs in order to meet Company goals and objectives • Responsible for design and execution of clinical studies including preparation of protocols, investigator brochures, clinical study reports, regulatory submissions and responses and other clinical program documents • Ensure the medical and scientific quality of clinical protocols, study data and clinical study reports • Identify and collaborate with clinical and post-marketing study investigators in alignment with the goals of clinical development activities and marketing initiatives • Assist in the preparation of publications, posters, and presentations for clinical programs • Collaborate with and provide scientific and clinical support and training for internal departments such as Sales, Clinical Operations and Research and externally for audiences such as health care providers • Prepare documents utilizing scientific and clinical data that comply with laws, regulatory, and industry guidance to appropriately respond to inquiries from healthcare professionals and managed care organizations • Ensure compliance with Good Clinical Practices, all applicable company guidelines, SOPs, laws, and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners
Experience and Skills
• Minimum of 8 years of clinical experience in the biotech/pharmaceutical industry • Strong background in clinical trial design and proven track record of timely and efficient execution of clinical programs in an industry setting • Demonstrated ability to analyze, interpret and present complex clinical and scientific data • Experience in quantitative data analysis and usage of data analytics applications • Strong organizational skills, attention to detail and the ability to manage multiple priorities and produce accurate and timely work in a highly-regulated environment • Ability to effectively work individually, within a multi-disciplinary team and with external vendors and clinicians • Excellent interpersonal communication and presentations skills with a proficiency in presenting clinical and non-clinical data to internal and external audiences • Thorough understanding of US healthcare environment, clinical research process, FDA and other federal regulations and ethical guidelines • Ability to travel (approximately 30%)
Telecommuting is allowed.
About Aziyo Biologics, Inc.
Aziyo Biologics, Inc. is a fully integrated regenerative medicine company focused on the development and commercialization of products in orthopedic, cardiovascular and other medical specialties. Our business model is simple, yet powerful. We aim to develop products that leverage the body’s natural healing mechanisms to create restorative solutions for patients. It is our commitment to the science behind these mechanisms and our expertise in product development that allow us to exceed the expectations of our corporate partners and patients every day.