Principal Scientist, Preclinical R&D - MedTech

About the role

At Johnson & Johnson MedTech, 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, working closely with cross functional groups within and external to the Preclinical Research group to meet project objectives.

Responsibilities

• 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:
  • 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

• 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.

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

Pay

The anticipated base pay range for this position is $117,000.00 – $201,250.00.

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k)).
• 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 period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.