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, Raritan, New Jersey, United States of America
Job Description:About SurgeryFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease, and cancer. Patients are waiting.
Our business offers a broad range of products and technologies, including surgical staplers, clip appliers, trocars and sealing devices-that are used in a wide variety of minimally invasive and open surgical procedures.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Johnson & Johnson MedTech is currently recruiting for a
Principal Scientist, Preclinical R&D - MedTech. The position can be located in
Raritan, NJ or
Cincinnati, OH. This position requires the candidate to work on site 5 days a week.
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:Under limited supervision and 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 concepts 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 vendors, 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 procedures.
- Performs other duties assigned as needed
Qualifications and Requirements:- 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.
- Previous experience working in a pre-clinical lab is required.
- Experience with large animal models is strongly preferred.
- 8+ years of experience in non-clinical research in a medical device or pharmaceutical industry setting is required.
- Knowledge of medical device regulations and regulatory and notified body requirements are required.
- Demonstrated ability to work cross functionally and influence a program direction is required.
- Business acumen and experience, including skills in budgeting, resource management, and staff development are required
- 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.
- Up to 20% travel is required, mostly domestic but can also be international.
#LI-Onsite
Required Skills:Preferred Skills:Compliance Risk, Cross-Functional Collaboration, Design Mindset, Developing Others, Drug Discovery Development, Execution Focus, Good Clinical Practice (GCP), Health Care Regulation, Human-Computer Relationships, Inclusive Leadership, Leadership, Medical Device Regulations, Medicines and Device Development and Regulation, Preclinical Research, Quality Control Testing, Research Ethics, Scientific Research, Team Management
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
