Vice President, Clinical Development - Ophthalmology

Stoke Therapeutics•Bedford, MA

7d•$380,000 - $440,000•Hybrid

About The Position

The Vice President of Clinical Development, Ophthalmology will provide strategic and operational leadership for Stoke Therapeutics’ ophthalmology pipeline, particularly therapies for rare and genetic retinal diseases. The role leads global clinical development strategies from early-stage programs through registration and life-cycle management, working across Research, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, and Commercial teams. The position serves as the medical and scientific leader for assigned programs and supports regulatory interactions, business development, and cross-functional governance. It also recruits, develops, and mentors clinical scientists and physician leaders, and helps establish clinical development and medical governance best practices. The role is hybrid, currently based in Bedford, Massachusetts, and will move to Waltham, Massachusetts after the company’s planned relocation by the end of 2026. Approximately 15% travel is required.

Requirements

M.D. or M.D./Ph.D. degree.
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.
Proven leadership experience managing cross-functional teams and influencing executive decision-making.
Excellent communication, presentation, and stakeholder engagement skills.

Nice To Haves

Board certification in Ophthalmology is strongly preferred.
Direct experience developing therapies for rare ophthalmic diseases and inherited retinal disorders.
Experience with gene therapy, gene editing, RNA-based therapies, or other advanced therapeutic modalities.
Track record of advancing programs through pivotal studies and regulatory approval.
Established relationships with leading ophthalmology investigators, retinal specialists, and academic centers.
Prior experience in a biotechnology company environment.

Responsibilities

Lead 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, aligning them with corporate objectives and portfolio strategy.
Design and oversee Phase 1–3 clinical trials, including protocol development, endpoint selection, statistical considerations, and interpretation of clinical studies.
Provide strategic leadership for interactions with FDA, EMA, PMDA, and other global health authorities.
Drive development plans to maximize technical, clinical, regulatory, and commercial success.
Partner with Clinical Operations, Biostatistics, Regulatory Affairs, Translational Medicine, Medical Affairs, and Commercial teams on program execution.
Represent programs on the Ophthalmology Program Team.
Chair clinical development teams and governance committees as appropriate.
Build and maintain relationships with key opinion leaders, investigators, patient advocacy groups, and strategic partners.
Support business development activities.
Recruit, develop, and mentor clinical scientists and physician leaders.
Foster scientific excellence, collaboration, accountability, and patient focus.
Establish clinical development and medical governance best practices across the organization.