Executive Medical Director of Ophthalmology, Clinical Development

Position Summary:

Apellis is seeking an experienced and visionary Executive Medical Director to lead clinical and strategic development efforts for the ophthalmology franchise, serving as the lead R&D representative on cross-functional strategy and development teams. This highly visible, senior leadership role combines responsibilities in clinical oversight, medical monitoring, and R&D strategy — driving programs from early development through to regulatory approval and lifecycle management. This role will be responsible for shaping the scientific and clinical direction of key ophthalmology programs, ensuring alignment with the company’s overall business goals and regulatory expectations. Reporting to the Head of Clinical Development, the Executive Medical Director will serve as a critical liaison between R&D and other key functions such as Commercial, Technical Operations, Medical Affairs, and Corporate Strategy.

Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided.

Key Responsibilities Include:

Strategic R&D Leadership:

• Act as the Lead R&D representative on cross-functional strategy and development teams, ensuring strategic alignment across research, clinical development, and commercial goals.
• Lead the creation and execution of Integrated Asset Plans, Target Product Profiles, and Lifecycle Management strategies for ophthalmology assets.
• Provide oversight of R&D deliverables across preclinical, CMC, and clinical development, ensuring adherence to timelines, scientific rigor, and regulatory readiness.
• Partner cross-functionally to integrate scientific strategy into commercial, regulatory, and technical operations planning.
• Drive internal alignment on program strategies including clinical trial design, regulatory submission planning, and global development considerations.

Clinical Development & Medical Oversight:

• Lead the clinical development strategy for ophthalmology programs from first-in-human through post-marketing.
• Serve as Therapeutic Area Lead for ophthalmology, overseeing all clinical development activities and ensuring delivery of high-quality clinical trials.
• Provide medical monitoring for ongoing clinical studies, including SAE review, coding, data interpretation, and safety oversight.
• Ensure medical and scientific integrity of clinical study reports, regulatory documents, and publications.
• Author and review clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, briefing documents), and represent Apellis in interactions with global health authorities.

Scientific and Regulatory Expertise:

• Serve as an internal and external scientific expert in ophthalmology, offering guidance on disease area trends, treatment landscapes, and development strategies.
• Shape the scientific direction of ophthalmology programs by integrating emerging science, innovation, and clinical insights.
• Collaborate with Regulatory Affairs to prepare for regulatory interactions, including advisory committee meetings and health authority consultations.
• Support business development efforts by contributing clinical and scientific assessments for in-licensing or partnership opportunities in ophthalmology.

Cross-Functional and Organizational Leadership:

• Represent Clinical Development and R&D in cross-functional leadership forums to drive alignment on strategic priorities, program risks, and operational execution.
• Foster a culture of scientific excellence, accountability, and innovation within the ophthalmology development team and across R&D.
• Coach and mentor direct reports and cross-functional colleagues, contributing to talent development and organizational capability building.

Education, Registration & Certification:

• MD, DO, or foreign equivalent required. 
• Board certification in ophthalmology strongly preferred. 

Experience:

• 10+ years of experience in drug development in the biotech/pharmaceutical industry, with 8+ years in ophthalmology clinical development.
• 5+ years in R&D or cross-functional leadership roles, with direct responsibility for program strategy and execution.
• Proven success in leading ophthalmology clinical programs across multiple development phases.
• Experience interacting with global regulatory agencies and presenting at advisory committee meetings.
• Deep understanding of ophthalmology diseases, clinical practice, and emerging therapies.
• Expert knowledge of the drug development lifecycle, including precl