Clinical Research Scientist
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 Clinical Research Scientist will be responsible for activities from the design of studies through to communication of results to the scientific and medical community. This individual will also develop data collection tools, perform data review, querying and analysis and participate in study 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 Vice President, Clinical Development
Essential Duties & Responsibilities:
- 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.
- Prepare publications, posters, and presentations for clinical programs
- Identify and collaborate with clinical and post-marketing study investigators in alignment with the goals of clinical development activities and marketing initiatives
- 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
Master’s degree, PhD or PharmD from an accredited college or university required
Experience and Skills:
- Minimum of 5 years of experience in the biotech/pharmaceutical industry or PharmD/PhD with 3+ years of experience
- Demonstrated ability to analyze, interpret and present complex clinical and scientific data
- Experience in quantitative data analysis and usage of data analytics applications
- Strong background in clinical trial design and execution in an academic or industry setting
- Strong organizational skills, attention to detail and the ability to manage multiple priorities and produce accurate and timely work in a highly-regulated environment
- Demonstrated success in drafting manuscripts for publication in peer-reviewed scientific and medical journals
- Ability to 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 (up to 50%)