Principal Clinical Research Scientist

Johnson & Johnson Innovative Medicine•Milpitas, CA

1d•$117,000 - $231,150•Hybrid

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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.

Requirements

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
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
Led clinical studies or clinical programs, not just participated in them
Experience designing studies and selecting endpoints
Demonstrated leadership on complex, cross-functional projects
Personally authored or substantially contributed to: Clinical study protocols, Clinical Study Reports (CSRs), Scientific abstracts, Manuscripts/publications
Can interpret study results independently
Comfortable working with biostatisticians on: Sample size assumptions, Endpoint strategy, Statistical analysis plans, Interpretation of results
Demonstrated ability to influence without direct authority
Experience partnering with R&D, Regulatory Affairs, Marketing, Medical Affairs, and Clinical Operations
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

Nice To Haves

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

Responsibilities

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
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