Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Multi-Family Pre-Clinical Development - Medtech
Job Category:People Leader
All Job Posting Locations:Cincinnati, Ohio, United States of America
Job Description:We are searching for the best talent for a Principal Scientist, Nonclinical Surgery located in Cincinnati, OH.
Purpose: Functioning as a primary surgeon, with a primary focus on cardiovascular procedures, to provide surgical expertise and technical leadership during research, development, and evaluation of surgical devices using animate, inanimate, and cadaveric models. Performing surgical research & testing which support development of products or procedures in standard and minimally invasive surgery (open, laparoscopic, and robotic).
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
- Conducting and / or directing surgical investigations for product development and preclinical evidence generation.
- Use scientific and surgical expertise to evaluate functionality, efficacy, and safety of medical devices during acquisition, licensure, discovery, development, and product change evaluations.
- Provide biomedical expertise by making unbiased recommendations to ETHICON teams regarding new technologies and interaction of device concepts on living tissue.
- Provide technical direction and execution within Preclinical Research for surgical investigation and development of medical devices.
- Collaborating with Preclinical Research team to apply clinically relevant models for product evaluation, while meeting preclinical study design, execution, and timeline requirements.
- Support the Preclinical Research team with the development of animal models.
- Responsible for communicating business related issues or opportunities to next management level
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Know & follow ETHICON policies & procedures related to work activities performed in area of responsibility.
- Utilize interpersonal skills and collaboration to enhance team processes and drive surgical efficiency/quality within Preclinical Research, ETHICON, and J&J.
- Function as key Preclinical Research team member by energetically supporting the goals of the department, ETHICON, and J&J by actively participating in and collaborating with the external scientific community.
- Performs other duties assigned as needed
Education:
- A minimum of a Doctorate degree is highly preferred (DVM/VMD from an (AVMA) American Veterinary Medical Association accredited program; MD is also acceptable with significant preclinical experience)
- Surgical residency training and board certification (DACVS) is preferred.
- Certification as a Surgical Research Specialist (SRS) through the Academy of Surgical Research may also be considered based on experience level.
- Demonstrated knowledge of surgical principles and theory is required, with specific training in cardiovascular procedures also required.
- Demonstrated knowledge and experience in performing fluoroscopic angiography in large animals is required
- Experience in executing preclinical and/or clinical studies, including GLP, with external contract research organizations is preferred.
- Ability to work collaboratively with the preclinical research team is required.
- Familiarity with Medical Device Product Development is preferred.
- Knowledge of preclinical regulatory requirements for FDA and notified bodies outside the US is preferred.
Required Skills & Experience:
- Extensive knowledge of cardiovascular surgery as well as interventional procedures.
- Deep knowledge of animal and human anatomy and physiology, as well as biological systems.
- Demonstrated analytical problem-solving and decision-making skills.
- Demonstrated surgical expertise during research, development, & evaluation by utilizing animate, inanimate and cadaveric models.
- Ability to work as a technical leader, team member, and role model for preclinical staff.
- Excellent communication skills - written/oral/listening.
- Working with minimal supervision.
- Ability to clearly document and communicate plans and results.
- Possess the motivation and work ethic to successfully complete studies/surgical procedures on time and with high quality.
- Able to manage multiple tasks and responsibilities.
- Serve as a preclinical subject matter expert on technical/surgical evaluation concerning device performance.
- Able to bring new scientific principles / innovative technical solutions to projects / studies.
- Robust surgical technique & mastery of open and laparoscopic procedures spanning multiple animal models. Robotic surgical experience is desired, but not required.
- Knowledge of regulations regarding medical device development and the utilization of live animals in preclinical research.
Other:
- This position is based in Cincinnati, OH, and requires up to 25% travel.
