Position Purpose: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 ideal candidate brings strong scientific judgment, demonstrated project management skills, experience with Medical, Legal, and Regulatory (MLR) review processes, and the ability to collaborate effectively in a fast-paced, evolving biotech environment.
Key Responsibilities Scientific Content and MLR Coordination - Develop, review, and maintain Standard Response Documents (SRDs), FAQs, and customized scientific responses, ensuring scientific accuracy, balance, consistency, and appropriate audience-specific 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 relevant stakeholders, and support timely approvals and content updates.
Inquiry Management and Scientific Support - Respond to HCP and patient/caregiver inquiries, including complex or escalated requests, using sound scientific judgment, literature evaluation, and consultation with subject matter experts.
- Support consistent 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.
Medical Information Operations and Vendor Oversight - Manage assigned components of daily MI 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.
Governance and Quality Management - Partner with the Senior Director to develop, implement, and maintain MI 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.
Reporting and Strategic Insights - Manage MI metrics and insights, ensuring accurate, 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 MI findings into clear reports and presentations for leadership and cross-functional stakeholders.
Required Skills and Experience - 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 MI, 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
Preferred Skills and Experience - Experience in rare disease and/or neurology,
- Experience in global MI operations, including audit and/or inspection support.
- Experience supporting outsourced MI operations, vendor performance, training, and quality improvement.
- Experience developing MI SOPs, content governance, and operational workflows.
- Experience scaling MI capabilities to support launch readiness and transitioning from clinical development to commercialization.
- Experience translating MI trends into recommendations and presenting insights to senior stakeholders.
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 is $185,000 - $210,000The 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).
