"Alerted.org

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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/Project Leader located in Cincinnati, OH.

Purpose: The Principal Scientist/project leader in the Preclinical Research department will serve as a key scientific contributor for the development and execution of strategies for preclinical evidence, necessary to competitively position products for domestic and international regulatory approval and clinical adoption. The individual will independently design, execute, analyze and interpret non-clinical studies to understand the safety and efficacy of product conceptual to final designs. 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:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

+ Serves as key team member, representing Preclinical Research on project core teams.

+ Provides scientific input on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle.

+ Responsible for partnering and contributing to the target product profiles, evidence generation strategies, and progression through the stage gate process.

+ Responsible for creating the non-clinical strategy and testing plan, as well as overseeing 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.

+ Communicates progress and milestone status to preclinical leadership, R&D partners, and others.

+ Participate in experiments to develop an understanding of customer unmet needs, potential misuse situations and to help interpret customer feedback to R&D team.

+ Collaborate with industrial design and human factors group to create robust usability evaluations.

+ Transfer of product development models and understanding to the Professional Education department, when needed.

+ Surveys the literature to identify and conduct competitive product performance assessment and safety risks.

+ Responsible for development of, and modifications to, preclinical models as needed to meet product requirements.

+ Serves as the preclinical subject matter expert for projects at First in Human Committee consultations and reviews.

+ Performs the role as designated Study Director for all types of non-clinical studies performed internally. As Study Director:

+ Is accountable and responsible for Study Protocol and Animal Use Protocol generation and approval.

+ Is accountable for procedural data collection, verification, and evaluation.

+ Is accountable for the quality and compliance of their assigned studies.

+ Is accountable and responsible for the Final Report generation and approval.

+ Performs the role of Preclinical Sponsor Oversight for all types of non-clinical studies performed at outside vendors (e.g., at CROs)

+ Identify external vendor, as needed, to execute non-clinical studies. Communicates to vendor management and contract group to initiate contract and audits, if necessary.

+ Provides input and reviews for study protocols and reports from external non-clinical studies.

+ Partner with members of the operations team to ensure external facilities meet JnJ standards for animal use and to generate contracts for vendors.

+ Responsible for communicating business related issues or opportunities to next management level.

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedure.

+ Performs other duties assigned as needed

Education & Required Skills/Experiences:

+ 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.

Required Skills & Experience:

+ At minimum 8 years of experience in non-clinical research in a medical device or pharmaceutical industry setting.

+ Knowledge of medical device regulations, regulatory/notified body requirements

+ Demonstrated ability to work cross functionally and influence a program direction

+ Excellent communication skills – written/oral/listening

+ Ability to clearly document and communicate plans and results

+ Lead and work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility

+ Business acumen and experience, including skills in budgeting, resource management, and staff development

+ Extensive knowledge of Preclinical Research

+ Knowledge of US FDA and other international regulations related to preclinical research

Other:

+ This position is based in Cincinnati, OH and requires up to 20% travel

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.