About Stoke

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose

The Vice President of Clinical Development, Ophthalmology will provide strategic and operational leadership for the clinical development of the company's ophthalmology pipeline, with a particular focus on innovative therapies for rare and genetic retinal diseases. This executive will be responsible for designing and executing global clinical development strategies spanning early-stage through registrational programs, working closely with Research, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, and Commercial teams.

The successful candidate will be an experienced physician leader with deep expertise in ophthalmology drug development and a demonstrated track record advancing novel therapies through clinical proof-of-concept, pivotal studies, and regulatory submissions. Experience in rare diseases, inherited retinal disorders, gene therapy or other advanced therapeutic modalities is strongly preferred.

Key Responsibilities

Clinical Development Leadership:

Lead the clinical development strategy for ophthalmology programs from IND-enabling activities through registration and life-cycle management.
Serve as the medical and scientific leader for assigned development programs, ensuring alignment with corporate objectives and portfolio strategy.
Design and oversee Phase 1-3 clinical trials, including protocol development, endpoint selection, statistical considerations, and clinical study interpretation.
Provide strategic leadership for regulatory interactions, including FDA, EMA, PMDA, and other global health authorities.
Drive development plans that maximize the probability of technical, clinical, regulatory, and commercial success.

Cross-Functional Leadership:

Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Translational Medicine, Medical Affairs, and Commercial teams to ensure successful program execution.
Serve as Program representative on the Ophthalmology Program Team
Chair clinical development teams and governance committees as appropriate.
Build and maintain strong relationships with key opinion leaders, investigators, patient advocacy groups, and strategic partners.
Support business development activities.

Team Development:

Recruit, develop, and mentor clinical scientists and physician leaders.
Foster a culture of scientific excellence, collaboration, accountability, and patient focus.
Establish best practices for clinical development and medical governance across the organization.

Required Skills & Experience

M.D. or M.D./Ph.D. degree required.
Board certification in Ophthalmology is strongly preferred.
Minimum of 12-15 years of biopharmaceutical industry experience, including substantial clinical development leadership responsibilities.
Demonstrated experience leading clinical development programs in ophthalmology.
Experience authoring or overseeing clinical development plans, protocols, investigator brochures, and regulatory submissions.
Strong understanding of global regulatory requirements and interactions with health authorities.