Staff Clinical Research Scientist

Staff Clinical Research Scientist

We are searching for the best talent to join our Vision team as a Staff Clinical Research Scientist located in Irvine, CA or Milpitas, CA.

Fueled 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 vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs from the pediatric to aging eye in a patient's lifetime.

Your unique talents will help patients on their journey to wellness.

Purpose: As a Clinical Scientist in the Surgical Vision platform, you will be part of a high-functioning team with core expertise in ophthalmology and medical device research. This role will particularly focus on supporting the J&J Vision Surgical Instrumentation platform of devices. You'll be an integral part of your cross-functional project teams, devising clinical strategy and delivering results that help create new products that drive the business. This role is best suited for clinically trained people who practice critical thinking, who are inventive, efficient and methodical, with a desire to work with industry leaders. This role will be responsible for conducting registered and non-registered clinical trials of products that have been determined to satisfy a medical need and/or offer commercial potential. You will oversee and interpret results of clinical investigations in preparation for marketing applications for software-driven medical devices/surgical instrumentation. You will provide scientific support in designing, conducting, monitoring, reporting and regulatory submission of clinical trials. You will play a key role in the review of the data for clinical trials, including reviews on eligibility, efficacy, safety, coding, protocol deviation, etc. Together with your team, you'll bring new technologies to doctors and their patients.

You will:

• Represent Clinical Science in cross-functional project team meetings, provide project team requirements as needed, with input/guidance from senior function members.
• Align with Clinical Operations team (study managers, CRAs) on project status/updates and identify issues or impact to project timelines as appropriate.
• Plan, design and develop/write documents required for clinical projects, including protocol outlines, protocol procedures, and reports.
• Draft, revise and perfect written materials in alignment with colleagues and partners to produce landmark scientific publications, including conference posters, KOL presentations, and technical or promotional documents.
• Operate in accordance with functional and enterprise SOPs, ensure training is complete and current.
• Evaluate and interpret clinical research data to ensure timely and accurate data analysis to be presented in a way that fairly and accurately reflects study results.

Qualifications:

• Bachelor's degree in a scientific field is required, advanced degree is preferred (Doctorate in Optometry or MD or Ph.D. or equivalent)
• At least 4 years of work experience in clinical or scientific research
• Strong background in ophthalmology, optometry, vision science & optics
• Strong writing ability
• Basic knowledge of statistics
• Proficient with computers and software, especially MS Word, Excel & PowerPoint

• Experience in class II/III medical device research, specifically surgical instrumentation
• Solid understanding of industry, regulatory and compliance requirements, including medical device software
• Well-versed in delivering clear, concise written and verbal communication
• Work effectively as part of a cross-functional global team

• Able to travel up to 25% (domestic and international)

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 (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Research Documents, Scientific Research, Standard Scientific Processes and Procedures

The anticipated base pay range for this position is:

$125,000.00 - $201,250.00

Additional Description for Pay Transparency:

The anticipated base pay range for this position- Non Bay Area is $109,000-$174,000. 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 period 10 days Volunteer Leave 32 hours per calendar year Military Spouse Time-Off 80 hours per calendar year For additional general information on Company benefits, please go to: -