Associate Director​/Director, Medical Information

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s.

We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

Cognito Therapeutics is seeking a driven, scientifically rigorous Associate Director/Director of Medical Information to build and lead the Medical Information (MI) function from the ground up. This is a hands‑on role suited to a motivated individual contributor who wants to establish strong operational foundations and deliver high‑quality scientific content in the Alzheimer’s and neurocognitive disease space. The role will design and implement core MI capabilities — inquiry management systems, standard response documents, and medical review workflows — positioning Cognito for its first commercial launch and for scaling as the pipeline grows.

The role will also contribute to Cognito’s Medical Affairs AI initiatives, bringing scientific and operational judgment to the responsible deployment of AI‑enabled tools for content generation and knowledge management.

• Establish the MI department from the ground up: operating model, technology infrastructure, and SOPs
• Develop and maintain the MI quality framework, ensuring all scientific content meets regulatory, compliance, and scientific‑integrity standards
• Serve as the internal subject matter expert on MI best practices, regulatory expectations (FDA, EMA/MDR/Notified Bodies), and industry benchmarks for neurocognitive disease and advanced therapies

• Build and oversee the medical review process for promotional and non‑promotional materials, ensuring scientific accuracy and alignment with labeling/IFU and clinical data
• Partner in establishing a Medical Review Committee (MRC) / Promotional Review Committee (PRC), working closely with Regulatory Affairs, Legal, and Commercial

• Create and maintain a comprehensive library of standard response documents (SRDs), custom responses, and medical FAQs covering Cognito’s neuromodulation device pipeline across neurocognitive disease indications
• Author and review medical information letters, and contribute to disease education materials, clinical summaries, and scientific dossiers for internal and external audiences
• Ensure all MI content reflects the current evidence base — clinical trial data, real‑world evidence, and peer‑reviewed literature

• Partner with Scientific Communications, Clinical Development, and Commercial to develop scientifically rigorous training materials, slide decks, and internal reference tools
• Lead development of pipeline and disease‑area resources enabling cross‑functional teams to communicate accurately about Alzheimer’s and the broader pipeline
• Contribute to publication planning and medical…