Sr Director, Clinical Development (Ophthalmology)

Position Overview

The Senior Medical Director will serve as the clinical lead for ophthalmology programs, with a focus on Ophthalmology indications. This role will oversee the design, execution, and analysis of clinical trials and play a key role in shaping development strategy.

Key Responsibilities

• Lead cross-functional study execution teams across clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance management

• Serve as medical monitor for clinical studies, ensuring patient safety and data integrity

• Author and review clinical development plans, study protocols, amendments, informed consent forms, investigator brochures, INDs, annual reports, clinical study reports, and regulatory submissions

• Organize and lead scientific advisory board meetings, engaging with external experts to inform program strategy

• Identify and assess new clinical opportunities in collaboration with research and portfolio teams

• Anticipate program risks and develop mitigation strategies

• Represent the company at external meetings, conferences, and with regulatory authorities

Qualifications

Education

• MD with residency training in Ophthalmology

Experience

• 8+ years of clinical ophthalmology research in the biopharmaceutical industry

• Proven experience leading Phase I=III clinical trials

• Gene therapy experience strongly preferred

• Experience contributing to NDA/BLA/MAA submissions

• Skilled in writing clinical research protocols, serving as a medical monitor, and interpreting clinical data

Skills

• In-depth knowledge of ICH-GCP and FDA regulatory guidelines; international regulatory familiarity is a plus

• Strong communication skills, both written and verbal, including public speaking