Director/Senior Director, Global Medical Information & Operations

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 approach, the company 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 entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights

STK-002 is Stoke’s proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Stoke’s initial focus is on 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 the Company’s proprietary approach.

Position Purpose:

Stoke Therapeutics is seeking an experienced and hands-on Medical Information leader to build, operationalize, and scale the Medical Information (MI) function in advance of commercialization.

This role will have end-to-end ownership of Medical Information, including contact center strategy and operations, scientific response content, inquiry management, and development of a scalable, digitally enabled self-service medical information portal.

This role requires strong operational rigor and a forward-looking mindset, with comfort working in ambiguity and establishing new ways of working. The ideal candidate brings a balance of scientific credibility, operational excellence, and curiosity about how Medical Information can continue to evolve in a growing organization.

Key Responsibilities:

Medical Information Strategy & Operations

• Lead the design, build, and ongoing operation of Stoke’s Medical Information function, including readiness for commercialization and oversight of internal and external resources
• Establish and manage the MI contact center model, including vendor onboarding, training, performance oversight, and scalability planning
• Define and implement MI operating model, SOPs, workflows, and governance in partnership with Legal, Compliance, Pharmacovigilance, and Clinical
• Lead development and ongoing management of a Medical Information portal to enable compliant, self-service access to approved content
• Build a scalable MI capability that integrates scientific exchange, structured content, and digital access

Scientific Content & SRL Oversight

• Lead the strategy, development, and lifecycle management of Standard Response Letters (SRLs) and scientific response content
• Ensure content accuracy, consistency, and appropriate risk framing aligned with clinical data, publications, and regulatory milestones
• Oversee MLR review processes for MI materials, ensuring timely approvals and compliance
• Partner with Medical Affairs, Clinical Development, and Publications to ensure alignment of scientific messaging

Inquiry Management & Compliance

• Oversee compliant handling of medical inquiries, including complex, escalated requests
• Ensure effective inquiry intake, triage, response timelines, and documentation in line with regulatory requirements
• Partner with Pharmacovigilance to ensure appropriate AE/PC identification and reporting
• Maintain audit and inspection readiness of MI processes and systems
• Promote high-quality, empathetic, and patient-centered communication

Systems, Analytics and Cross-Functional Leadership

• Serve as business owner for MI systems (e.g., CRM), including configuration, optimization, and integration with data infrastructure
• Partner with IT, Medical Operations, and Analytics to ensure MI data flows into enterprise systems and supports reporting needs
• Define and monitor MI KPIs and dashboards, translating data into actionable insights
• Lead oversight and performance management of MI vendors (e.g., contact center, content support), including training, QA, and continuous improvement
• Act as the primary operational liaison across Medical Affairs, Clinical, Legal, Compliance, and Pharmacovigilance
• Leverage internal and external resources to support content development and ensure high-quality, consistent scientific responses

Required Skills & Experience:

• Advanced degree (PharmD, MD, PhD, or equivalent scientific background)
• 7+ years of experience in Medical Affairs within biotech/pharma, with demonstrated experience in Medical Information, including scientific response content and/or inquiry management
• Demonstrated experience building or scaling Medical Information capabilities in a pre-commercial or early commercial environment
• Strong working knowledge of SRL development, inquiry handling, and MLR processes
• Experience with MI contact center models (in-house and/or outsourced)
• Experience working with MI systems and platforms (e.g., CRM), including ownership or optimization
• Proven ability to manage vendors and operate effectively in a regulated, cross-functional environment

Preferred Skills & Experience:

• Rare disease and/or neurology experience preferred
• Exposure to medical portals, digital MI solutions, or AI-enabled tools
• Demonstrated interest in evolving Medical Information through digital solutions, process innovation, or new operating models

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 remote.

Travel:

This position will require approximately 10% 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 at the Director level is $232,000 - $262,000 and at the Sr. Director level is $279,000 - $321,000. 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).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:

https://www.stoketherapeutics.com/careers/

For more information, visit https://www.stoketherapeutics.com/.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.