Director/Senior Director, Global Medical Information & Operations

Stoke Therapeutics•Bedford, MA

11h•Remote

About The Position

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. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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
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