Senior Medical Director, Clinical Development, Ophthalmology
Regeneron Pharmaceuticals, Inc.
Senior Medical Director, Ophthalmology Therapeutic Area
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Medical Director to join our Ophthalmology Therapeutic Area, supporting clinical development programs from first-in-human through registration-enabling studies. In this role, you will serve as scientific and medical lead for clinical team(s), guiding development strategy and regulatory submissions while collaborating with Internal Medicine leadership, executive leadership, development partners, and global regulatory agencies. This role reports to the Vice President, Ophthalmology Therapeutic Area Lead.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: Tarrytown, NY; Cambridge, MA; or Warren, NJ
- Travel: 10% to relevant conferences
Discover your role:
- Act as medical expert and leader in interactions with external stakeholders, internal stakeholders, and decision boards
- Develop innovative clinical strategies to shorten development cycles amid an evolving regulatory landscape
- Design efficient, robust Phase 1, 2, and 3 programs
- Partner with research and discovery teams to inform the next generation of targets in the field
- Safeguard patient safety in clinical studies and support signal detection from post-marketing surveillance
- Ensure the quality of clinical documents, including investigator brochures, protocols, study reports, and regulatory submission materials
- Draft responses to regulatory agency questions and prepare regulatory submission documents
- Build consensus and drive sound decision-making across dynamic, matrixed clinical teams
This role requires:
- MD or equivalent medical degree, with board certification or eligibility in Ophthalmology
- Minimum of 4 years of industry experience in early or late clinical development (candidates with strong academic backgrounds and less experience may be considered)
- Experience leading proof-of-concept and/or registrational clinical trials, including protocol design and study execution
- Solid knowledge of global regulatory requirements (ICH) for pharmaceutical development
Vacancy posted 5 days ago
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