Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - Non-MD
Job Category:Scientific/Technology
All Job Posting Locations:Irvine, California, United States of America, Jacksonville, Florida, United States of America, Milpitas, California, United States of America
Job Description:JOB POSITION SUMMARY
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. Learn more at https://www.jnj.com/medtech
We are searching for the best talent to join our Vision team, as Principal Clinical Research Scientist , J&J Vision, located preferably in Jacksonville, FL, Milpitas, CA, or Irvine, CA.
Purpose:The Principal Clinical Research Scientist for Vision is an expert in ophthalmic and medical device research who serves as a core team member on key projects and leads a team of Staff Clinical Scientist. This role provides strategic and scientific leadership for the development and execution of clinical programs that generate robust evidence to support innovative vision care products and technologies. Leveraging deep expertise in clinical research, product development, and ophthalmic regulations, the Principal Clinical Research Scientist influences development strategies, aligns cross-functional stakeholders, and drives successful execution of complex initiatives that improve outcomes for eye care professionals and their patients.
You will be responsible for:Represent Clinical Science as core team member on critical projects, liaising
between project and functional teams, and coordinating with Clinical Operations
and Project Management partners to deliver on time, within budget, and in
compliance with regulations and SOPs.
Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle.
Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.).
Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections
Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies
Performs other related duties as assigned by management.
Qualifications / Requirements:
Education- Advanced degree in scientific discipline (required)•
- OD, MD/Ophthalmologist, or PhD in Vision Science/related field strongly preferred
- Post-graduate training, residency, or fellowship preferred
Ophthalmic Expertise- 5+ years of ophthalmic clinical research experience
- Deep understanding of eye care, ophthalmic devices, vision science, or related therapeutic areas
- Experience supporting product development and lifecycle management
Clinical Research Leadership- Led clinical studies or clinical programs, not just participated in them
- Experience designing studies and selecting endpoints
- Demonstrated leadership on complex, cross-functional projects
Technical Writing• Personally authored or substantially contributed to:
- Clinical study protocols
- Clinical Study Reports (CSRs)
- Scientific abstracts
- Manuscripts/publications
Scientific & Statistical Acumen
- Can interpret study results independently•
- Comfortable working with biostatisticians on:
- Sample size assumptions
- Endpoint strategy
- Statistical analysis plans
- Interpretation of results
Communication & Influence
- Demonstrated ability to influence without direct authority
- Experience partnering with R&D, Regulatory Affairs, Marketing, Medical Affairs, and Clinical Operations
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS
- Strong technical writing ability, such as clinical study protocols, reports and abstracts is required
- Understanding of biostatistics as applied to study data is required
- Proficient with computers and software programs is required
TRAVEL REQUIREMENTS
Up to 10% of domestic or international travel is required
Required Skills:Preferred Skills:Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
For Bay Area:
$134,000.00 - $231,150.00
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)).
This position is eligible to participate in the Company's long-term incentive program.
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
