This position is a key member of the Company’s senior leadership team and as such is involved in setting the Company’s long-term vision and short- term goals and objectives.
The position will be responsible for the leadership and oversight of clinical study operations by organizing and coordinating the planning, implementation, management, execution and completion of clinical programs according to applicable regulations and guidance, ICH and GCP, and Aziyo operating procedures related to medical devices, biologics and 361 human tissue products. This position will also be responsible for the development of clinical systems/processes and effective communication within and outside the corporation related to the implementation of processes and successful completion of studies.
This position reports to EVP, Regulatory & Scientific Affairs
Essential Duties & Responsibilities:
Manage the development process for clinical systems and critical study documents, including.
Support clinical studies activities with regard to protocol development, data collection, data analysis and reporting requirements, to include but not limited to: Postmarket study reports, US FDA Supplements, Progress Reports, and other required reports (e.g., site enrollment); European Union notified body clinical study interim and final reports in support of CE mark activities; adverse event reporting to quality assurance, as appropriate; local Ethics Committee and Institutional Review Board (IRB) submissions as they relate to regulatory requirements during the course of clinical trials.
Work with Marketing and Sales Department to develop post-marketing studies to support marketing strategies and develop data to support peer review articles and presentations for meetings.
Point of contact for development of abstracts, posters and other publications
Determines study objectives, strategy, scope and schedule in order to meet business needs.
Develop study materials, including investigator’s brochures, regulatory binders, and case report forms.
Oversees data management activities (e.g. creation of CRFs, CRF completion guides, data management plan, monitoring plan, actual monitoring data validation).
Interfaces with statisticians regarding analysis plans, report tables, audits and logic checks.
Oversees maintenance of all clinical (site) files.
Interfaces with central IRB(s).
Creates clinical SOPs and guidelines as necessary, and is responsible for ensuring compliance.
Selects, interfaces with, and assures training of investigators and clinical staff.
Ensure adequate monitoring is conducted on all clinical trials.
Enlists support and specifies tasks for various clinical team members to assure meeting study objectives/schedule.
Communicates study progress site and company personnel on a regular basis.
Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and provide advice on direction.
Provides input and support for planning post-clinical activities and market launch of products.
Develops and manages budgets for assigned studies, including allocating payments to sites for CRF completion and for study activities/procedures (if applicable).
Controls device distribution and allocation.
All other duties and responsibilities as assigned.
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.