Associate Director, Medical Information
- Location
- Bedford, Massachusetts, United States; Remote
- Employment type
- unknown
- Posted
- Posted
- Medical Affairs
About the role
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 TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke 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’s initial focus are 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 Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ 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. <li data-leveltext="" data-font="Symbol" data-listid="29" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level=
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