Nuvaira, Inc. is a medical device company focused on improving the lives of patients using minimally invasive obstructive lung disease therapy. We are seeking an experienced Scientist to support pre-clinical and clinical trial analysis and reporting in the Scientific Affairs organization. The role includes scientific expertise and support for pre-clinical and clinical study reports and publications, as well as the preparation of results for presentation and evidence dissemination. This role will work with statisticians, engineers, and other cross-functional areas.
This individual, reporting to the Director, Scientific Affairs, will be responsible for:
- Scientific and technical writing of study summaries and reviews of the relevant literature for internal and external consumption
- Acting as an internal resource on the biological/mechanistic aspects of the Nuvaira system and treatments.
- Translation of complex scientific concepts into publications and presentations Lead experimental design and execution, as well as root-cause analysis, recommendations and procedural modifications
- In-depth and thoughtful analysis and summarization of data.
- Serve as a scientific expert and resource for the clinical studies team in application of pre-clinical learning’s during planning of clinical studies and analytical evaluation of clinical study results
- Research current literature relevant to the field, maintain library of relevant literature, and disseminate information internally for the benefit of the entire Nuvaira team.
- Analyze scientific data, document results, and prepare reports.
- Develop and deliver effective presentations, reports and publications internally and externally
- Explain biological science/mechanism of Nuvaira therapy for regulatory and other external groups based on the known literature, and the learning’s from clinical and pre-clinical studies.
- Support root-cause analysis evaluation and generate recommendations on system or procedure modifications.
- Write/review reports, proposals, scientific articles, invention disclosure, patent applications, etc.
- Support scientific strategy development
- Execute simultaneous projects according to fluid business objectives and priorities
- Travel <25%
- Minimum Masters Degree, Ph.D. strongly preferred, in engineering or biological sciences or equivalent.
- Experience in experimental design and implementation.
- Experience in medical and/or technical writing
- Experience in scientific and/or medical presentations
- Minimum 5 years experience in medical device or related field preferred
- Experience in healthcare economics outcomes research (HEOR)
- Experience in pre-market medical technology
- Desire to improve knowledge in, and keeping up with advances in, (and in wider areas) and leading procedural changes where necessary.
- Strong presentation and scientific writing skills
- Strong organizational and follow-up skills, as well as attention to detail.
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.