Associate Director / Director, Medical Information

Cognito Therapeutics, Inc.; Cambridge (MA); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Unlimited PTO

Wellness perks

Virtual medical support

Health, dental, and vision insurance

Job summary

Cognito Therapeutics is seeking an Associate Director/Director of Medical Information to build and lead the MI function from the ground up. This hands‑on role will establish the operating model, technology infrastructure, and SOPs to deliver high‑quality scientific content for Alzheimer’s and neurocognitive diseases.

You will create SRDs, manage medical review workflows, and partner with Regulatory Affairs, Legal, Commercial, and Clinical Development to ensure compliant, accurate content.

Qualifications

• Advanced scientific degree required (PharmD/MD/PhD or equivalent).
• 6+ years of Medical Information experience in device/pharma/biotech.
• Strong writing and communication skills for internal/external audiences.
• Experience building MI capabilities, SOPs, and content libraries.
• Familiarity with FDA/EMA/MDR regulatory requirements.

Responsibilities

• Build the MI function from the ground up, including operating model, tech, and SOPs.
• Develop and maintain the MI quality framework and regulatory alignment.
• Lead medical review processes and establish MRC/PRC with cross‑functional teams.

Skills

Scientific writing

Communication skills

Cross-functional collaboration

Regulatory compliance knowledge

Strategic leadership

Education

PharmD/MD/PhD or equivalent

Tools

Veeva Vault

Salesforce Health Cloud

MedAnswers

Job description

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.

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 audiences
• 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

Competitive Benefits

Taking care of our own is one of our highest priorities. That’s why we offer benefits including unlimited PTO, wellness perks, virtual medical support, and health, dental, and vision insurance.

Physical Requirements & Work Environment

• This role is primarily performed in an office or home‑office setting. Essential physical requirements include the ability to work at a computer for extended periods, communicating effectively in written and verbal formats, and participate in video and in‑person meetings.
• Occasional travel to Cognito’s Cambridge, MA office or partner sites may be required.

Cognito Therapeutics is committed to providing reasonable accommodation for qualified individuals with disabilities throughout the application and hiring process. If you require accommodation, please contact us at [e-mail].

Cognito Therapeutics is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and make employment decisions based on qualifications, merit, business needs, and job requirements. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

All applicants must be legally authorized to work in the United States.