Principal Clinical Research Scientist
$117,000–$201,250 year
On-siteIrvine, California, United States or Jacksonville, Florida, United States
Job Summary
Represent Clinical Science as a core team member on critical projects, liaising between project and functional teams to deliver programs on time, within budget, and in compliance with regulations. Activate collaborative relationships with Global Strategic Marketing, Medical Affairs, Regulatory Affairs, and R&D to ensure consistent alignment across the product lifecycle. Lead initiatives for the interpretation and dissemination of evidence, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents. Contribute to clinical scientific discussions with regulatory agencies to support investigations and marketing authorization, while engaging with key opinion leaders and professional societies.
Required Qualifications
- Advanced degree in scientific discipline
- 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
- Strong technical writing ability, such as clinical study protocols, reports and abstracts
- Understanding of biostatistics as applied to study data
- Proficient with computers and software programs
- Up to 10% of domestic or international travel
Desired Qualifications
- OD, MD/Ophthalmologist, or PhD in Vision Science/related field
- Post-graduate training, residency, or fellowship
- Experience partnering with R&D, Regulatory Affairs, Marketing, Medical Affairs, and Clinical Operations
- Contribute to clinical scientific discussions with regulatory agencies
- Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies
- Build on relationships established through professional/technical societies
- Demonstrated ability to influence without direct authority
- 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
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