Axogen is looking to advance peripheral nerve science and its clinical applications by leading and managing clinical research activities. This role will focus on driving the development and execution of clinical strategies that support product efficacy, safety, and regulatory compliance.
Requirements
- In-depth knowledge of clinical trial design, regulatory requirements, and GCP.
- Experience with FDA submissions, including INDs, BLAs, PMAs, and/or 510(k)s.
- Expertise in clinical trial design, data analysis, and regulatory submissions, ideally within the biotech or medical device industries.
Responsibilities
- Lead the design and development of clinical study protocols, including objectives, endpoints, sample size determination, and statistical analysis plans.
- Oversee the execution of clinical studies, ensuring compliance with Good Clinical Practice (GCP), relevant regulations, and company standards.
- Provide scientific oversight and ensure clinical data integrity and quality throughout the study.
- Collaborate with biostatistics and data management teams to ensure accurate data analysis and reporting.
- Interpret clinical study results and generate clinical study reports, publications, and presentations.
- Provide scientific input on interim analyses, final analyses, and any safety-related issues that arise during the trial.
- Support product development by integrating clinical evidence into product design, development, and labeling.
Other
- Minimum 5 years of experience in clinical research in the biotech or medical device industry, including experience in leading clinical trials.
- Strong leadership skills with the ability to work in cross-functional teams.
- Excellent written and verbal communication skills, including the ability to present complex clinical data to both scientific and non-scientific audiences.
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
