Senior Scientist – MedTech Surgery, Inc. Full-time

Senior Scientist – MedTech Surgery

We are searching for a Senior Scientist – MedTech Surgery to be in Cincinnati, OH.

The Senior Scientist/project leader in Preclinical Research will serve as a scientific contributor for the development and execution of strategies for preclinical evidence necessary to competitively position a project's product for domestic and international regulatory and clinical acceptance. The individual will contribute to the design, execution, analysis, and interpretation of preclinical studies to understand the safety and efficacy of product concepts. The individual will work closely with cross functional groups within and external to the Preclinical Research group to meet project objectives.

You will be responsible for:

• Liaison with Business Partners:
• Collaborate in planning and executing in animate studies supporting Design Validation.
• May serve as core team member representing the Preclinical Research on project teams.
• May provide preclinical scientific input on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle.
• May contribute to the Target Product Profile (TPP), evidence generation strategies, and per NPD stage gate process.
• May be responsible for creating the Preclinical strategy and plan, and overseeing study execution per project timelines.
• May attend core team meetings and serves as a single point of contact for communication between the project team and functional groups within the Preclinical Research group.
• Works cross functionally with Medical Affairs, Safety, Regulatory, and Quality to assess project risks, product safety and efficacy on NPD projects.
• Communicate and monitor the risks associated to the preclinical evaluation of product concept for projects to ensure success.
• May collaborate with industrial design and human factors group for usability evaluations. Participate in labs, as needed, to develop understanding of customer unmet needs, potential misuse situations and help interpret customer feedback to R&D team.
• Communicating progress and milestone status to preclinical leadership, R&D partners, and others.
• Surveys the literature to identify and conduct competitive product performance assessment and safety risks.
• Responsible for the design of preclinical functionality and safety animal studies.
• Preclinical Sponsor Oversight:
• May sponsor studies at external labs (academic, CRO), as needed, to execute preclinical animal studies.
• Partner with members of the operations team to ensure external facilities meet JnJ standards for animal use and to generate contracts for vendors.
• Preclinical Internal Study Execution:
• Functions as a Good Laboratory Practices Study Director when designated.
• As Study Director:
• Is accountable and responsible for Protocol and IACUC Proposal development and approval.
• Is accountable for procedural data collection, verification, and evaluation.
• Is accountable for the quality and compliance of the assigned studies.
• Is accountable and responsible for the Summary Report development and approval.
• Will function as a Study Coordinator in support of a Study Director:
• Is responsible collaborating on Protocol and IACUC Proposal development and approval.
• Is accountable for managing the logistics for lab execution. Such as, lab requests, animal requests, test article management, blood collection, document preparation, and study documentation preparation for archival.
• Is responsible for investigating and documenting study deviations and non-conformances for Study Director assessment.
• Is responsible for in life data collection and study execution oversight during surgical procedures.
• Is responsible collaborating with the Study Director on the Summary Report development and approval.
• Facilitate support for the conduct, monitoring and reporting, of preclinical studies (Service, Evaluations, and Protocol, and GLP Protocol) in Preclinical Research facilities via the coordination of communications, documentation, and test/control article logistics.
• Serves as the single point of contact with the Study Director to communicate timelines, issues, and milestones regarding study conduct.

Qualifications/Requirements:

• Minimum of a Master's degree is required; Doctorate degree strongly preferred. Fields of study include biological sciences, biomedical engineering, or veterinary medicine.
• At least 4+ years of Industrial research, academic research, or product development experience required. (2+ years for Doctorate)
• Knowledge of the requirements of in vivo preclinical study conduct and GLP regulations is required.
• Experience with large animal preclinical studies is highly desired.
• Demonstrated ability to engage and develop relationships with project leaders to facilitate study execution is required.
• General knowledge of Preclinical Research is required. Knowledge of US FDA, UDSA and other international regulations related to preclinical research is highly desired.
• General knowledge of animal and human anatomy and physiology, surgical principles & theory, as well as biological systems.
• Demonstrated ability to work cross functionally is required.
• Influencing and negotiating skills.
• Demonstrated analytical, problem solving, and decision-making skills.
• Develop tactics to successfully complete programs/projects/studies.
• Strong communication skills – written/oral/listening.
• Ability to clearly document and communicate plans and results.
• Working with minimal supervision.
• Ability to work as a team member, as well as early team leadership skills.
• Independent decision-making skills as appropriate.
• Conceptualize issues and represent organizational needs accordingly.
• Able to handle multiple tasks and responsibilities.
• Able to articulate scientific basis for decisions to project team partners.
• Position requires approximate 25% domestic and some international travel as needed.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.