Vice President, Clinical Development - Ophthalmology

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.
• Proven leadership experience managing cross-functional teams and influencing executive decision-making.
• Excellent communication, presentation, and stakeholder engagement skills.

Preferred Skills & Experience:

• 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.

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position currently based in Bedford, MA and will be based in Waltham, MA after the move.

Travel:

This position will require approximately 15% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $380,000 - $440,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).