Ophthalmology Clinical Development Architect (MD)

BioSpace; Village of Tarrytown (NY); Sur place; USD 333 000 - 451 000; Plein temps

Résumé du poste

Regeneron is seeking a Senior Medical Director to join the Ophthalmology Therapeutic Area, guiding clinical development from first-in-human through registration-enabling studies. You will lead clinical strategy, regulatory submissions, and cross-functional collaboration with internal and external stakeholders.

Location options include Tarrytown, NY; Cambridge, MA; or Warren, NJ. 10% travel to conferences and a focus on patient safety and high-quality clinical documentation.

Qualifications

• MD or equivalent medical degree, board certification or eligibility in Ophthalmology.
• Minimum of 4 years of industry experience in early or late clinical development.
• 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.

Responsabilités

• 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.

Connaissances

Clinical leadership

Trial design

Regulatory submissions

Cross-functional leadership

Formation

MD or equivalent medical degree

Description du poste

Regeneron is seeking a Senior Medical Director to join the Ophthalmology Therapeutic Area, guiding clinical development from first-in-human through registration-enabling studies. You will lead clinical strategy, regulatory submissions, and cross-functional collaboration with internal and external stakeholders.

Location options include Tarrytown, NY; Cambridge, MA; or Warren, NJ. 10% travel to conferences and a focus on patient safety and high-quality clinical documentation.