Director of Clinical Operations
Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular, and other medical specialties. Our mission is to restore health and mobility through the development of innovative new solutions that expand the possibilities of regenerative medicine.
This position is responsible for the design, analysis, interpretation and reporting of clinical study data to support Aziyo’s corporate goals. The Director of Clinical Operations will be responsible for all activities from the design of studies through communication of results to the scientific and medical community. 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. The company currently has post market clinical programs in a number of therapeutic areas including cardiovascular and orthopedics.
Position reports to the Chief Medical Officer.
Essential Duties & Responsibilities:
- Contribute leadership in developing and be responsible for executing the overall Aziyo clinical program strategy
- Provide oversight of operation of all Aziyo clinical programs in order to meet Company goals and objectives
- Responsible for the management of the budget and spending for all Aziyo clinical programs.
- Responsible for design, analysis, interpretation and reporting 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
Bachlelor’s degree in a scientific discipline from an accredited college or university or an equivalent combination of education and work experience required.
Experience and Skills:
- Minimum of 5 years of progressive clinical experience and responsibility in the medical device, or 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
- Prior experience managing direct reports desirable.
- Ability to travel (up to 30%)