The company is looking to develop and execute strategies for preclinical evidence to competitively position products for domestic and international regulatory approval and clinical adoption.
Requirements
- Knowledge of medical device regulations, regulatory/notified body requirements
- Extensive knowledge of Preclinical Research
- Knowledge of US FDA and other international regulations related to preclinical research
- Experience with non-clinical research in a medical device or pharmaceutical industry setting
- Ability to clearly document and communicate plans and results
- Business acumen and experience, including skills in budgeting, resource management, and staff development
Responsibilities
- Design, execute, analyze and interpret non-clinical studies to understand the safety and efficacy of product conceptual to final designs
- Create the non-clinical strategy and testing plan, as well as oversee study execution per project timelines
- Assess, communicate, and manage the risks associated with the non-clinical evaluation of product concept for projects to ensure success
- Develop and modify preclinical models as needed to meet product requirements
- Serve as the preclinical subject matter expert for projects at First in Human Committee consultations and reviews
- Perform the role as designated Study Director for all types of non-clinical studies performed internally
- Identify external vendor, as needed, to execute non-clinical studies
Other
- A minimum of a Master’s Degree in biomedical engineering or a related discipline is required
- Doctorate degree in biomedical engineering or a related discipline, or veterinary medicine is preferred
- At minimum 8 years of experience in non-clinical research in a medical device or pharmaceutical industry setting
- Excellent communication skills – written/oral/listening
- Ability to lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility
- Up to 20% travel required
