Associate Director / Director, Medical Information

Associate Director / Director, Medical Information

Cambridge, Massachusetts, United States Cognito Therapeutics Associate Director / Director, Medical Information Reports to: Head of Medical Affairs

About the Role

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.

Responsibilities

Build the Medical Information Function

• 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

Medical Review & Compliance

• 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

Scientific Content & Deliverables

• 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 use
• Ensure all MI content reflects the current evidence base clinical trial data, real-world evidence, and peer-reviewed literature

Cross-Functional Partnership & Medical Affairs Strategy

• 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 education initiatives supporting pre- and post-launch Medical Affairs strategy
• Collaborate with Patient Advocacy and Scientific Communications to ensure content is accessible, accurate, and patient-centered
• Partner closely with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other functions to support compliant scientific exchange and launch readiness.

Medical Affairs AI Initiatives

• Contribute as the Medical Affairs subject matter expert to Cognito's AI strategy, partnering with Data Science, IT, and Medical Affairs leadership to evaluate and implement AI-enabled solutions
• Support design and validation of AI-assisted MI tools, including intelligent response generation, literature-surveillance automation, and content quality-checking workflows
• Help establish governance frameworks for responsible AI use in medical communications bias assessment, hallucination mitigation, and compliance review protocols
• Monitor the evolving regulatory and industry landscape around AI in medical affairs (FDA guidance, ISPE, PhRMA frameworks) and translate insights into actionable policy

Qualifications

Required

• Advanced scientific degree: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field
• Minimum 6 years of Medical Information experience in the device, pharmaceutical, or biotechnology industry. Associate Director/Director title level is commensurate with years of experience and required qualifications
• Deep understanding of Medical Information regulations and compliance requirements
• Experience contributing to or building MI capabilities, including SOP development and content library management
• Solid working knowledge of medical review processes (MRC/PRC) and promotional/non-promotional content review, with familiarity with applicable FDA and EMA/MDR regulations
• Strong scientific writing skills, with experience developing SRDs, MI responses, and clinical content for internal and external audiences
• Excellent written and verbal communication skills, with the ability to translate complex scientific and clinical data into clear, compliant messaging
• Ability to work effectively cross-functionally in a fast-paced, pre-commercial biotech environment with lean teams and evolving priorities
• Excellent interpersonal skills, with the ability to build credibility and trust inside and outside the company

Preferred

• Knowledge of Alzheimer's and other neurocognitive diseases
• Experience supporting pre-market approval/pre-BLA activities and commercial launch readiness for first-in-class therapies; device experience is a plus
• Experience with KOL engagement, vendor management, and scientific content analytics
• Familiarity with MI platforms (e.g., Veeva Vault, Salesforce Health Cloud, MedAnswers) or emerging AI-powered MI solutions
• Exposure to AI/ML applications in Medical Affairs or Medical Information, including prompt engineering, LLM evaluation, or AI governance

Other

• Hybrid position preferred; flexibility required during peak periods, which may include supporting critical operations outside normal business hours as needed