Associate Director, Medical Information

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🔥 2 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 10%

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Stoke Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $125M Post-IPO Equity - Stoke Therapeutics on 2024-03

Biotechnology • Pharmaceuticals • Healthcare

Stoke Therapeutics is a biotechnology company developing RNA-based therapeutics that increase protein production from a patient’s own genes to treat rare genetic diseases. Its TANGO (Targeted Augmentation of Nuclear Gene Output) platform uses antisense oligonucleotides to upregulate gene expression in haploinsufficiency disorders. Lead programs include STK‑001, an antisense therapy in development for Dravet syndrome (SCN1A haploinsufficiency), and other programs focused on genetic neurology and rare disease indications.

📋 Description

• Develop, review, and maintain Standard Response Documents (SRDs), FAQs, and customized scientific responses • Partner on content planning and prioritization for inquiry needs, emerging data, publications, regulatory milestones, and launch readiness • Coordinate Medical, Legal, and Regulatory (MLR) submissions, resolve stakeholder feedback, and support timely approvals and content updates • Respond to healthcare professional and patient/caregiver inquiries, including complex or escalated requests • Support inquiry intake, triage, documentation, and escalation practices • Monitor response quality and timeliness and report adverse events and product complaints to Pharmacovigilance and Product Quality • 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 • Partner with the Senior Director on vendor performance, scope, capacity, budget inputs, resource recommendations, corrective actions, and continuous improvement • Coordinate scientific and operational training for vendors and internal stakeholders • Develop, implement, and maintain Medical Information SOPs, work instructions, quality standards, and training documentation • Maintain inspection-ready records and support audits, inspections, and remediation activities • Identify operational and compliance risks, recommend improvements, and provide scientific and operational guidance • Manage Medical Information metrics and insights and analyze inquiry trends, content gaps, scientific needs, and operational performance • Synthesize Medical Information findings into reports and presentations for leadership and cross-functional stakeholders • Report to the Senior Director, Medical Information & Operations

🎯 Requirements

• 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 • Advanced degree (PharmD, PhD, or equivalent scientific background) preferred • Approximately 10% travel • Experience in rare disease and/or neurology preferred • Experience in global Medical Information operations, including audit and/or inspection support preferred • Experience supporting outsourced Medical Information operations, vendor performance, training, and quality improvement preferred • Experience developing Medical Information SOPs, content governance, and operational workflows preferred • Experience scaling Medical Information capabilities to support launch readiness and transitioning from clinical development to commercialization preferred • Experience translating Medical Information trends into recommendations and presenting insights to senior stakeholders preferred

🏖️ Benefits

• Annual bonus • Equity participation • Medical insurance • Dental insurance • Vision insurance • Life insurance • Long-term disability insurance • Short-term disability insurance • Paid parental leave • 401K plan with company match • Unlimited vacation time • Tuition assistance • Employee Stock Purchase Program (ESPP) • Flexible work arrangements

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