About this role
Role Overview
- Plays a key role in clinical development programs within the Ophthalmology portfolio
- Serves as scientific and medical lead for clinical team(s) working closely with operational leads
- Collaborates with multi-disciplinary clinical teams, assisting in guiding and executing clinical development strategies and regulatory submissions
- Responsible for the design and execution of first-in-human through registration-enabling studies
- Acts as medical expert and leader in interactions with external and internal stakeholders
- Develops unique and innovative clinical strategies to shorten development cycle
- Ensures safety of the drug and quality of all clinical documents
- Develops written responses to regulatory agency questions and prepares regulatory submission documents
Requirements
- A M.D. or D.O. or equivalent medical degree and relevant training
- A trained Ophthalmologist (board certified or eligible or equivalent) is essential.
- A minimum of 4 years of industry experience (early or late clinical development); however, a candidate with a strong academic background and less experience may be considered.
- Experience in leading proof of concept and/or registrational clinical trials, including protocol design, managing study start-up, directing, and guiding study team execution, data cleaning, medical monitoring/review, database locks.
- Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required.
- A strong commitment to clinical research and the ability to work well within a team setting are essential.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)