Chief Executive Officer & Co-Founder
Stealth-Mode AI Biomarker, HealthTech Venture
Pre-Seed | Equity-Only | Remote-First
The Venture
We are building a smartphone-based AI platform that detects early neurocognitive impairment through on-device sensors and multi-modal cognitive stimuli. The system delivers automated, personalized intervention pathways across three converging clinical contexts: concussion management, mild cognitive impairment, and neurodegenerative disease monitoring. The addressable market is $4.2B, the regulatory pathway is mapped, and the founding scientific and clinical team is in place.
What this venture now needs is the technical founder who turns a defensible digital biomarker thesis into a clinically validated, FDA-cleared, production-grade mobile platform.
The Role
The Chief Executive Officer & Co-Founder will own vision, capital strategy, commercial roadmap, regulatory strategy, and external positioning across the global digital health, neurology, sports medicine, and aging-care ecosystems. True zero-to-one founder seat with full operational authority and material founder equity, reporting to the board. The CEO will partner closely with the CTO on platform and regulatory technical execution, with the CSO on clinical validation and scientific credibility, and with the COO on operational discipline — leading the venture from formation through pre-seed close, clinical validation, FDA clearance, and commercial traction.
This is not a role for a healthcare generalist. It is a founding seat for a commercial leader with genuine fluency across digital health commercialization, FDA-regulated medical device pathways, and multi-stakeholder clinical buyer dynamics — and the conviction to build a category-defining company in a market that incumbents have approached cautiously.
A direct word on compensation
This is a founding equity seat. No salary at this stage. We are not looking for a hired CEO — we are looking for a co-owner who will architect the commercial trajectory of the venture from zero and carry it through FDA clearance, Series A, and category leadership. If that is the seat you have been waiting for, the rest of this posting is written for you.
Core Responsibilities
- Define and articulate the company's vision and category positioning — smartphone-based AI for early neurocognitive impairment detection across concussion, MCI, and neurodegenerative monitoring — to investors, clinical partners, regulators, payers, employers, analyst firms, and strategic acquirers.
- Lead pre-seed and seed capital strategy: investor targeting, data-room construction, term-sheet negotiation, and cap-table architecture.
- Own the strategic narrative defending the multi-modal smartphone digital biomarker thesis: why traditional in-clinic cognitive assessment fails on access, frequency, and longitudinal sensitivity; why single-modality digital tools (voice-only, drawing-only, reaction-time-only) are structurally limited; and why a multi-modal smartphone-native platform with personalized intervention pathways is the architectural answer the category has not yet seen executed at scale.
- Architect the clinical validation and FDA regulatory strategy in coordination with the CSO and CTO: indication sequencing, predicate strategy for 510(k) or De Novo pathway, AI/ML-enabled SaMD predetermined change control plan positioning, FDA Breakthrough Device Designation pursuit where appropriate, and parallel European MDR planning.
- Architect the multi-vertical commercial sequencing decision: concussion management (sports medicine, military, pediatric), mild cognitive impairment (primary care, Medicare Advantage), and neurodegenerative monitoring (neurology specialty, pharmaceutical companion programs). The three verticals share a platform but require distinct go-to-market motions, validation cohorts, and capital intensities. The CEO must arrive with a strong opinion on phasing and the discipline to defend it against the temptation to pursue all three concurrently.
- Build commercial relationships across the target buyer landscape: health systems and academic medical centers, sports organizations (NFL, NHL, NCAA, professional soccer, MMA, military), senior living operators, payer innovation teams (UnitedHealth Optum, CVS Aetna, Humana, Anthem Elevance, Clalit, Maccabi), and pharmaceutical partners pursuing real-world evidence in CNS therapeutics (Biogen, Eisai, Eli Lilly, Roche, Novartis).
- Position the product against incumbents — Linus Health, Altoida, BrainCheck, Cognoa, Akili Interactive, Neurotrack, MyndYou, Savonix — with a wedge anchored on multi-modal sensor fusion, smartphone-native deployment, and personalized intervention pathways.
- Pursue non-dilutive funding: NIH (NIA, NINDS, NIMH), NSF, ARPA-H, DOD CDMRP (concussion-relevant programs), BIRD Foundation, Horizon Europe Health, and Alzheimer's Drug Discovery Foundation partnerships.
- Drive IP strategy in coordination with patent counsel: continuation filings, PCT execution, defensive expansion across the multi-modal smartphone neurocognitive sensing claim space, FTO analysis, and trade-secret architecture.
- Engage proactively with the digital health regulatory and standards landscape: FDA Digital Health Center of Excellence, Digital Therapeutics Alliance, and emerging AI/ML SaMD guidance.
- Recruit founding team across clinical operations, regulatory affairs, sales, customer success, and marketing — in partnership with the COO's people operations infrastructure.
- Establish governance: board composition, scientific advisory board (neurology, sports medicine, geriatrics, neuropsychology), and clinical advisory board.
- Manage runway, milestones, and investor reporting appropriate to a regulated digital health capital trajectory — clinical milestone discipline, FDA submission timelines, and the unit economics of multi-vertical commercialization.
Required Qualifications
- 15+ years of operating leadership, including a prior CEO, GM, or CRO role at a digital health, medical device, digital therapeutics, or adjacent regulated health-tech venture.
- Demonstrable track record raising institutional capital in digital health or medical device ventures — pre-seed through Series B+ — from tier-one healthtech or medtech investors.
- Direct experience navigating an FDA 510(k), De Novo, or equivalent Software as a Medical Device clearance pathway — ideally for an AI/ML-enabled digital device.
- Substantive commercial experience across at least two of: health system enterprise selling, sports organization partnership development, payer innovation contracting, employer-paid digital health, or pharmaceutical real-world evidence partnerships.
- Working understanding of the neurocognitive assessment commercial landscape: in-clinic cognitive testing economics (MoCA, MMSE, ImPACT), digital biomarker category dynamics, and the operational realities of clinical workflow integration.
- Direct experience navigating health data and clinical regulatory pathways: HIPAA architecture, FDA SaMD classification, AI/ML-enabled medical device guidance, and the wellness-versus-medical-device delineation that shapes commercial strategy.
- Technical literacy sufficient to credibly defend the multi-modal smartphone digital biomarker thesis to skeptical investors, clinicians, and regulators.
- Experience structuring strategic partnerships with health systems, sports organizations, payers, or pharmaceutical CNS franchises.
Preferred Qualifications
- Prior exit (acquisition or IPO) in digital health, digital therapeutics, digital biomarkers, or mobile medical device software — Linus Health, Altoida, Cognoa, Akili Interactive, Pear Therapeutics, Livongo, Omada Health, or comparable lineage particularly valued.
- Direct operating experience inside a tier-one digital health, medtech, or pharmaceutical digital health corporate (Verily, Apple Health, Google Health, Otsuka Digital Health, Biogen Digital Health, Roche Information Solutions, Medtronic Digital).
- Established investor relationships within the digital health and medtech syndicate (General Catalyst, Andreessen Horowitz Bio + Health, GV, Section 32, F-Prime, OrbiMed, 7wireVentures, Define Ventures, Optum Ventures, OurCrowd, and equivalents).
- Prior experience working alongside scientific co-founders at the IP-to-company translation stage in a neurology, neuroscience, or digital biomarker category.
- Direct relationships with sports league medical leadership (NFL Head Health Initiative, NHL Player Safety, NCAA Sport Science Institute) or military medical research leadership (USAMRDC, DOD CDMRP).
- Familiarity with the Alzheimer's disease therapeutic landscape and the emerging companion-diagnostic opportunity created by anti-amyloid therapeutics (lecanemab, donanemab) — increasingly the most strategically important adjacency in the MCI vertical.
- Operating familiarity with Medicare Advantage commercial dynamics and the CMS reimbursement pathway for digital cognitive assessment (CPT codes 99483, 96132–96146).
Compensation Structure
- Co-Founder equity. Material, vesting on standard terms with appropriate cliff and acceleration.
- No salary at pre-seed stage. Cash compensation reviewed and instated at institutional close.
- Founder-level participation in subsequent funding rounds.