Full-Time
Associate Director / Director
Medical Information
Cognito Therapeutics
51-200 employees
Non-invasive neuromodulation device for neurodegenerative diseases
No salary listed
Cambridge, MA, USA
Hybrid
Hybrid role; some after-hours work during peak periods.
PharmD, PhD, MD
 Medical, Clinical & Veterinary (1) |
|---|
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- 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
- 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
- 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
Cognito Therapeutics develops medical devices that use non-invasive neuromodulation to treat neurodegenerative diseases like Alzheimer's. The main product is a wearable or non-invasive device that delivers electrical stimulation to targeted brain regions to modulate nerve activity, supported by services and potentially accompanying therapies. The company earns revenue from selling its devices and related services, and may pursue partnerships with larger device makers and healthcare institutions as well as grant funding. Its approach centers on proprietary technology for non-invasive brain modulation, aiming to improve patient outcomes in a field with few effective options. The goal is to bring scalable neuromodulation treatments to patients worldwide and establish a clear path from research and development to commercialization in the MedTech space.
Company Size
51-200
Company Stage
Series C
Total Funding
$263M
Headquarters
Cambridge, Massachusetts
Founded
2016
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Simplify's Take
What believers are saying
- Cognito closed an oversubscribed $105 million Series C in March 2026.
- HOPE fully enrolled, with topline data expected in 2026, creating near-term catalyst.
- AAIC 2026 biomarker data showed CSF lipid-transport increases, strengthening mechanistic credibility.
What critics are saying
- Cognito v. OptoCeutics filed January 6, 2026, exposes core patent vulnerability.
- HOPE remains unapproved and topical FDA approval timing slips crush 2027 launch plans.
- If HOPE misses cognition endpoints, Spectris becomes a scientific curiosity, not a business.
What makes Cognito Therapeutics unique
- Spectris targets Alzheimer's with at-home synchronized light-and-sound neuromodulation, not infusions.
- FDA granted Spectris Breakthrough Device Designation in 2021, validating an unusual modality.
- Ochsner and WVU collaborations give Cognito real-world delivery channels beyond academic trials.
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Benefits
401(k) Retirement Plan
Remote Work Options
Health Insurance
Paid Vacation
Flexible Work Hours
Wellness Program
Growth & Insights and Company News
6 month growth
↓ -3%1 year growth
↓ -3%2 year growth
↓ -3%New at-home Alzheimer's treatment could be made available to Ochsner patients next year. Baton Rouge / louisianaradionetwork.com Jul 26, 2026 | 3:08 PM A new at-home treatment for Alzheimer's disease could soon be available, and Ochsner Health is partnering with the company behind the technology. Ochsner regional medical director Dr. Richard Zweifler says Cognito Therapeutics has developed the Spectris headset, which uses brain stimulation to help slow the disease. "The flashing lights and sounds at a certain frequency that looks to be very beneficial to the brain in terms of protecting it from functional decline over time," Zweifler said... The device is still in clinical trials and has not been approved by the FDA. But Zweifler says early results show the therapy may help remove the plaque associated with Alzheimer's. "To be able to slow that decline, and preserve cognition, preserve the ability for patients with this disease to communicate and have a high quality of life," Zweifler said. Ochsner expects FDA approval could come by next June. Through its partnership with Cognito Therapeutics, Zweifler says the goal is to make the treatment available to Ochsner patients as soon as possible. "If we have an option to slow the decline that's game changing," Zweilfer said. Patients would wear the headset for one hour a day, and Zweifler says side effects appear to be minimal. An estimated 95,000 Louisianans are living with Alzheimer's disease. Researchers hope the Spectris headset could provide a less invasive alternative to infusions or oral medications.
AAIC26: Cognito sheds light on biological underpinnings of Alzheimer's headset. Spectris increased CSF levels of multiple HDL-like lipid transport proteins, suggesting a "coordinated biological response" to the neuromodulation therapy. New data from Cognito Therapeutics has indicated that its Spectris device increases cerebrospinal fluid (CSF) HDL-like lipid transport particles, suggesting the neuromodulation therapy prompts a "coordinated biological response" in patients with mild cognitive impairment (MCI). Spectris is an investigational device that delivers synchronised auditory and visual stimuli to evoke gamma brain waves, with the aim to slow brain atrophy, preserve cognition, and improve daily functioning in patients with Alzheimer's disease. The headphone-like device secured breakthrough device designation from the US Food and Drug Administration (FDA) in 2021. While the fundamental biological workings of the device was already known, the new data unveils the specific pathways triggered by the therapy. During a poster presentation at the 2026 Alzheimer's Association International Conference (AAIC), taking place in London, UK between 12-15 July, Cognito shared data from its Phase II FLICKER study that is evaluating daily Spectris sensory stimulation in patients with amyloid-positive MCI. Using a mass spectrometry-based proteomics analysis, investigators found that daily Spectris treatment increased CSF levels of multiple HDL-like lipid transport proteins, including APOA1, APOA2 and APOL1. Pathway analysis further demonstrated that 13 of the 29 significantly upregulated biological pathways were associated with lipid transport or metabolism. Calling the findings "particularly notable" given the lipid transport proteins were identified through an unbiased proteomics screen, Cognito said they suggest that a "coordinated biological response", rather than isolated protein changes, is taking place in this patient population following Spectris treatment. APOA1 is known to be associated with Alzheimer's disease biology, with published studies demonstrating an inverse relationship between CSF APOA1 levels and phosphorylated tau (pTau181), further supporting the biological relevance of this pathway, the company stated. Cognito also highlighted that its analysis identified clear involvement of oligodendrocyte/myelination (M36) co-expression module, a pathway associated with myelin integrity and white matter biology. These findings resonate with previously reported MRI observations from Cognito's OVERTURE feasibility study that suggests Spectris treatment may result in the preservation of white matter and myelin. Cognito's CEO, Christian Howell, commented: "Every new dataset helps Medical Device Network build a more complete understanding of how non-invasive neuromodulation may impact the biology of Alzheimer's disease. "The unbiased identification of coordinated lipid transport and myelination pathways is an encouraging finding that reinforces its scientific hypothesis and expands its understanding of Spectris' potential mechanism of action. "Although these analyses are exploratory, they provide an important rationale for evaluating these biomarkers in future clinical studies as we continue advancing a new category of neuroprotective therapies." Cognito anticipates that it will be set to launch its Alzheimer's disease therapeutic in the US by 2027. To support this effort, the company completed a $105m Series C financing round in March 2026. Give your business an edge with its leading industry insights.
Cognito Therapeutics to present New Data highlighting effects of Spectris(TM) on Lipid Transport Biomarkers in Alzheimer's Disease at AAIC 2026. Company to present data demonstrating increases in CSF HDL-like lipid transport proteins following Spectris(TM) therapy CAMBRIDGE, Mass.-(BUSINESS WIRE)-Cognito Therapeutics, a clinical-stage neurotechnology company developing disease-modifying therapies for neurodegenerative disorders, today announced that new data evaluating the Spectris(TM) investigational device in Alzheimer's disease will be presented at the Alzheimer's Association International Conference (AAIC) 2026, held July 12-15, 2026, in London, UK. The poster presentation will highlight exploratory proteomic findings showing that Spectris(TM) increased cerebrospinal fluid (CSF) levels of HDL-like lipid transport proteins in amyloid-positive MCI participants, supporting further investigation of lipid transport modulation as a potential brain resilience pathway in Alzheimer's Disease. "We are encouraged to present additional biomarker data at AAIC 2026 that continue to deepen our understanding of the biological effects of Spectris therapy in Alzheimer's disease," said Christian Howell, CEO, Cognito Therapeutics. "Our focus remains on developing a non-invasive therapy that can be used at home and has the potential to fit more seamlessly into the daily lives of people living with Alzheimer's." Poster presentation details are as follows: Abstract Title: Spectris(TM) Sensory Stimulation Increases CSF HDL-like Lipid Transport Proteins In Alzheimer's Disease Session Title: Biomarkers (non-neuroimaging) Presenter: Ralph Kern MD MHSc Poster Number: 2023 Session Number: P2-06 Presentation Date / Time: Monday, July 13, 2026, 7:30 AM - 4:30 PM BST Location: Excel London, Exhibit Hall About Cognito Therapeutics Cognito Therapeutics is a late clinical-stage neurotechnology company pioneering neuroprotective therapies to address the unmet needs of patients living with CNS disorders and support broader brain health. Its lead product, Spectris(TM), is an investigational at-home neuroprotective therapy platform that uses non-invasive, sensory-driven neurostimulation to evoke gamma frequency brain activity. The company's feasibility studies have shown the potential for Spectris to preserve cognition, daily function, and slow brain atrophy in patients diagnosed with mild-to-moderate AD. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx. Contacts. Media Contact Cia Burbank Cognito Therapeutics [email protected] Kimberly Ha KKH Advisors 917-291-5744 [email protected] More News From Cognito Therapeutics CAMBRIDGE, Mass.-( BUSINESS WIRE )-Cognito Therapeutics Partners with Initiative to Change the "D-Word," Commits to Eliminating Use of "Dementia" Across All Communications... CAMBRIDGE, Mass. & NEW ORLEANS-( BUSINESS WIRE )-Cognito Therapeutics and Ochsner Health launch Brain Health Collaboratory to advance new care models for Alzheimer's disease... CAMBRIDGE, Mass.-( BUSINESS WIRE )-Cognito Therapeutics Presents New Data on Spectris(TM) in Alzheimer's Disease at AD/PD(TM) 2026...
Cognito Therapeutics and Ochsner Health launch Brain Health Collaboratory to advance new care models for Alzheimer's disease. Thursday, March 26, 2026 Cognito Therapeutics, a late clinical-stage neurotechnology company pioneering non-invasive neuroprotective therapies in neurodegenerative diseases, today announced a collaboration with Ochsner Health, a leading health system serving Louisiana, Mississippi and the Gulf South, to launch a Brain Health Collaboratory aimed at advancing new approaches to treating cognitive decline and Alzheimer's disease. The Ochsner Collaboratory establishes the Gulf South's first statewide platform for non-invasive brain health innovation, combining Cognito's investigational Spectris technology platform with Ochsner's expansive clinical network to explore new models for brain health care delivery across both urban and rural communities throughout the region. The Ochsner Neuroscience Institute serves as a top destination for comprehensive neurological care between Houston and Atlanta, providing access to patients across a broad and diverse geographic area. The expert level of care provided to patients will be elevated with the addition of a new 132,000 square-foot, state-of-the-art facility. The Debra H. and Robert J. Patrick Neuroscience Institute at Ochsner Medical Center in New Orleans, set to open in late 2026, will bring Ochsner's nationally renowned neurosciences programs under one roof, offering a seamless, patient-centered experience. "This new collaboratory affords us the opportunity to pair emerging neurotechnology with real-world clinical care to better understand how we can slow cognitive decline, improve patients' lives and open new therapeutic pathways for other neurological diseases in the future," said David Houghton, MD, system chair of neurology, Ochsner Health. Ochsner and Cognito will work to develop a Brain Health Index, a framework designed to better track cognitive health, disease progression, and treatment response in real-world care settings. The program will also explore opportunities to integrate Cognito's investigational Spectris(TM) therapy into clinical care models for patients experiencing cognitive decline. "Ochsner's reach across the Gulf South provides a unique opportunity to bring innovative brain health technologies to a broad patient population," said Christian Howell, chief executive officer of Cognito Therapeutics. "Partnerships like this are essential to ensuring that new therapies can reach patients not just in major academic centers, but across entire healthcare systems that serve both urban and rural communities. Expanding access to patients is critical to generating real-world evidence and ultimately delivering new options for people living with Alzheimer's disease." The Ochsner Brain Health Collaboratory will also explore pathways to integrate Spectris into programs serving dual-eligible Medicare and Medicaid populations, an area where Alzheimer's disease places significant clinical and economic burden. The collaboration will seek to generate clinical and health economics data to better understand the cost-effectiveness of non-invasive neuromodulation therapies and their role within value-based care models, including potential exploration of coverage pathways with payors. Together, Cognito and Ochsner aim to develop a new framework for brain health measurement, care delivery, and evidence generation, helping to accelerate the translation of innovative therapies from research to real-world clinical practice. At the core of the Brain Health Collaboratory initiative is Spectris(TM), Cognito's investigational, non-invasive neuroprotective device designed for at-home use. Spectris delivers synchronized light and sound stimulation through the brain's natural sensory pathways to promote healthy neural network activity and has shown early promise in preserving brain structure and function in Alzheimer's disease. The technology may also hold potential across a range of neurological conditions, including Parkinson's disease, multiple sclerosis, traumatic brain injury, stroke, and addiction. In 2021, Spectris received the Breakthrough Device Designation by the U.S. Food and Drug Administration, recognizing its potential to transform neurodegenerative care. It is currently being evaluated in clinical trials under the HOPE Trial. "We are proud to partner with Cognito Therapeutics and advance this groundbreaking brain health initiative in the Gulf South," said Pete November, president and chief executive officer, Ochsner Health. "Partnerships like this are only possible because of the extraordinary talent and dedication of our physicians, advanced practice providers, nurses, and support and administrative teams across neurosciences. Additionally, the unwavering support of Bobby and Debbie Patrick, along with other generous donors, have made our soon-to-be open neuroscience institute a reality. Together, we are building a future where innovation and compassionate care come together to transform lives." Cognito launched its first Brain Health Collaboratory in November 2025 with the West Virginia University Rockefeller Neuroscience Institute (RNI), a pioneering initiative designed to accelerate the discovery, validation, and real-world delivery of non-invasive neuroprotective therapies. The collaboration with Ochsner builds on Cognito's broader vision to establish a network of Brain Health Collaboratories with leading health systems and academic medical centers to expand patient access, generate real-world evidence, and accelerate innovation in brain health. In 2022, Debra (Debbie) and Robert (Bobby) Patrick made a transformational and groundbreaking contribution to establish Ochsner's new neuroscience facility. Their deep commitment to Ochsner's mission empowers its neuroscience medical teams to deliver innovative technologically advanced treatments to help improve quality of life. "True medical excellence comes from combining expert, compassionate care with the most advanced technology available. By integrating breakthrough innovation into daily practice, Ochsner is building a proactive future for brain health. The Debra H. And Robert J. Patrick Neuroscience Institute will be a place where technology and expert medical treatment meet in one state-of-the-art facility, ensuring the highest standard of care for our communities. My family and I are excited for what's to come," said Bobby Patrick, New Orleans businessman, entrepreneur and managing partner, Patrick Family Foundation. To learn more about the Ochsner Neuroscience Institute, visit Ochsner.org/neurosciences. About Ochsner Health Ochsner Health is the leading nonprofit healthcare provider in Louisiana, Mississippi and across the Gulf South, delivering expert care at its 47 hospitals and more than 370 health and urgent care centers. Ochsner is nationally recognized for inspiring healthier lives and stronger communities through expertise, quality and digital connectivity. In 2025, more than 40,000 dedicated team members and 5,000 employed and affiliated physicians at Ochsner cared for more than 1.6 million people from every state in the nation and 65 countries. To learn more about how Ochsner empowers people to get well and stay well, visit www.ochsner.org. About Cognito Therapeutics Cognito Therapeutics is a late clinical-stage neurotechnology company pioneering neuroprotective therapies to address the unmet needs of patients living with CNS disorders. Its lead product, Spectris(TM), is an investigational at-home neuroprotective therapy platform that uses non-invasive, sensory-driven neurostimulation to evoke gamma frequency brain activity. The company's feasibility studies have shown the potential for Spectris to preserve cognition, daily function, and slow brain atrophy in patients diagnosed with mild-to-moderate AD. Cognito is headquartered in Cambridge, MA. For more information, visit www.cognitotx.com and follow @cognitotx. Contacts Media: Cognito Therapeutics Kimberly Ha KKH Advisors 917-291-5744 [email protected] Source: businesswire.com
Cognito Therapeutics has partnered with Ochsner Health to launch a Brain Health Collaboratory in the Gulf South, advancing new care models for Alzheimer's disease. The collaboration will combine Cognito's investigational Spectris technology with Ochsner's clinical network across Louisiana, Mississippi and surrounding areas. The partnership will develop a Brain Health Index to track cognitive health and disease progression whilst exploring integration of Spectris therapy into clinical care. The collaboratory will also examine coverage pathways for dual-eligible Medicare and Medicaid populations. Spectris, which received FDA Breakthrough Device Designation in 2021, delivers synchronised light and sound stimulation for at-home use. It is currently being evaluated in the HOPE Trial. This marks Cognito's second Brain Health Collaboratory, following a November 2025 launch with West Virginia University's Rockefeller Neuroscience Institute.