Associate Director, Medical Information

Stoke Therapeutics•Bedford, MA

19h•$185,000 - $210,000•Remote

About The Position

Stoke Therapeutics is seeking an experienced Medical Information professional to support the execution and continuous improvement of Medical Information programs and operations. Reporting to the Senior Director, Medical Information & Operations, the Associate Director will help translate functional strategy into effective processes, high-quality scientific content, and accurate, timely, and compliant responses to healthcare professional and patient/caregiver inquiries. In partnership with the Senior Director, this individual will manage assigned projects across scientific content, inquiry response, vendor oversight, governance, and insight reporting, collaborating cross-functionally to support compliant scientific exchange. The position is remote and requires approximately 10% travel. Stoke allows flexibility in work arrangements while emphasizing periodic in-person collaboration. The role supports Stoke Therapeutics, a biotechnology company developing RNA medicines using its proprietary TANGO approach. Its first medicine in development, zorevunersen, is being evaluated in a Phase 3 study for Dravet syndrome.

Requirements

Advanced degree (PharmD, PhD, or equivalent scientific background preferred).
6–8+ years of experience within biotech/pharma, including at least 3 years in Medical Information or closely related scientific communications activities.
Experience developing scientific response content, evaluating literature, responding to medical inquiries, and supporting MLR review.
Strong working knowledge of laws and regulations applicable to Medical Information, including nonpromotional scientific exchange, safety reporting, and data privacy.
Strong scientific writing, communication, analytical, and organizational skills.
Ability to collaborate across functions, exercise sound judgment, and manage competing priorities.
Familiarity with inquiry management, content management, or MLR platforms, such as Veeva PromoMats, SharePoint, or equivalent systems.
Comfort working in a fast-paced, evolving environment.

Nice To Haves

Experience in rare disease and/or neurology.
Experience in global Medical Information operations, including audit and/or inspection support.
Experience supporting outsourced Medical Information operations, vendor performance, training, and quality improvement.
Experience developing Medical Information SOPs, content governance, and operational workflows.
Experience scaling Medical Information capabilities to support launch readiness and transitioning from clinical development to commercialization.
Experience translating Medical Information trends into recommendations and presenting insights to senior stakeholders.

Responsibilities

Develop, review, and maintain Standard Response Documents (SRDs), FAQs, and customized scientific responses, ensuring scientific accuracy, balance, consistency, and audience-appropriate language.
Partner on content planning and prioritization to address inquiry needs, emerging data, publications, regulatory milestones, and launch readiness.
Coordinate Medical, Legal, and Regulatory (MLR) submissions, resolve feedback with stakeholders, and support timely approvals and content updates.
Respond to healthcare professional and patient/caregiver inquiries, including complex or escalated requests, using scientific judgment, literature evaluation, and consultation with subject matter experts.
Support consistent inquiry intake, triage, documentation, and escalation practices.
Monitor response quality and timeliness and ensure prompt reporting of adverse events and product complaints to Pharmacovigilance and Product Quality in accordance with established procedures.
Support medical congress activities and partner with Field Medical on inquiry intake, handoff, and escalation.
Manage assigned components of daily Medical Information operations and outsourced contact center services, including service levels, deliverables, response quality, training, and issue resolution.
Partner with the Senior Director on vendor performance, scope, capacity, budget inputs, and resource recommendations; support corrective actions and continuous improvement.
Coordinate scientific and operational training for vendors and internal stakeholders and contribute to readiness for emerging data, program milestones, and potential launch.
Partner with the Senior Director to develop, implement, and maintain Medical Information SOPs, work instructions, quality standards, and training documentation.
Maintain organized, inspection-ready records and support audits, inspections, and remediation activities with relevant functions.
Identify operational and compliance risks, recommend improvements, and provide scientific and operational guidance to colleagues and vendor staff.
Manage Medical Information metrics and insights, ensuring accurate and consistent analysis of key activities and performance to inform strategic and operational decisions.
Analyze inquiry trends, content gaps, emerging scientific needs, and operational performance to inform content priorities and improvement recommendations.
Synthesize Medical Information findings into clear reports and presentations for leadership and cross-functional stakeholders.