Senior Business Development Leader

Business Development Founding Team Atlanta-preferred · Remote (US) Full-time

Senior Business Development Leader

Healthcare AI / Regulated Markets — Reports to Founder / CEO

About Precoh

Precoh turns AI regulation into real-world deployment. Our platform, RegOS , transforms fragmented regulatory requirements (FDA SaMD, EU MDR, IMDRF) into structured, executable, and auditable workflows — so clinical AI can be evaluated, approved, and scaled with confidence.

Alongside RegOS, our advisory practice runs sandbox-readiness sprints, regulated-AI experiment design, and implementation pilots for three buyer types:

• Regulators and sandbox operators running consistent, reproducible evaluations across AI submissions.
• Health systems evaluating third-party AI before procurement and across the post-market lifecycle.
• AI and MedTech companies running pre-submission evaluations before FDA or EU MDR filing.

We are early, founder-led, and revenue-generating. This is a foundational commercial role on our team.

Why this role exists

The regulatory-AI market is forming in real time, and the buyers — Chief AI Officers, CMIOs, regulatory affairs leaders, sandbox operators — are sophisticated, technical, and skeptical of generic GTM motions. We are looking for a commercial leader who can sit across the table from a Chief AI Officer at a multi-hospital system, a regulator running a SaMD sandbox, and a clinical‑AI startup preparing for submission — and translate Precoh's regulatory infrastructure into structured pilots, signed engagements, and a repeatable pipeline.

This is a build-the-engine role. You will own the commercial motion end-to-end and grow a team underneath you.

What you will own

• Stand up Precoh's commercial operating system: ICP definition, target-account list, CRM, outbound, deal stages, and forecast.
• Codify Precoh's service offerings into clean packages, scoping templates, and pricing playbooks.
• Run discovery with qualified buyers and produce written buyer‑insight memos that sharpen positioning, packaging, and pricing.
• Own a self-sourced pipeline and convert it across health systems, regulators / sandbox operators, and AI/MedTech vendors.
• Lead complex, multi‑stakeholder pursuits across Chief AI Officers, regulatory affairs, IT/security, procurement, and clinical leadership.
• Land and shape design‑partner engagements with regulators and sandbox operators.
• Partner with the founder on category creation: thought‑leadership, conference presence (HIMSS, RSNA, AdvaMed, FDA workshops), and analyst briefings.
• Hire and ramp the next commercial roles (BD/AE and a sales engineer / regulatory solutions lead) and build out a partner channel with QMS vendors, CROs, AI assurance firms, and advisory practices.

What you will do day‑to‑day

• Run technical discovery — confidently discuss FDA SaMD risk classes, 510(k) vs. De Novo, EU MDR Class IIa/IIb, predetermined change control plans (PCCPs), Good Machine Learning Practice (GMLP), bias and fairness evaluation, post‑market surveillance, and AI assurance frameworks (NIST AI RMF, ISO/IEC 42001, IMDRF).
• Translate buyer pain into RegOS evaluation scope, evidence packages, and decision artifacts.
• Build proposals, MSAs, and SOWs alongside the founder; negotiate pricing, success criteria, and data‑use terms.
• Maintain a live point of view on the competitive landscape — AI assurance startups, QMS vendors, advisory practices, and academic evaluation labs.
• Run the deal desk: forecast accuracy, pipeline hygiene, and weekly commercial reviews.
• Produce written artifacts — buyer memos, deal reviews, win/loss analyses — at a level that ships externally.

Must‑have qualifications

• 8+ years in business development, commercial strategy, or GTM leadership, with at least 3 years selling a technical product or advisory service into healthcare, life sciences, or another regulated industry .
• Demonstrated wins with one or more of: US health systems / academic medical centers, regulators or sandbox operators, AI/MedTech companies, or pharma R&D and clinical operations.
• Working fluency in regulated‑AI vocabulary: SaMD, FDA premarket pathways, EU MDR, IMDRF, clinical validation, model risk management, AI governance, bias/fairness, post‑market monitoring.
• Track record of large, complex enterprise deals with multi‑stakeholder cycles spanning procurement, security, legal, and clinical.
• Founder‑mode operator: you have built a pipeline from a blank CRM, written your own decks, and run your own demos.
• Exceptional writing. You can produce a buyer memo, a 1‑pager, and an investor‑grade narrative without hand‑holding.
• Atlanta‑based or willing to spend material time here. Remote considered for exceptional candidates.

Strongly preferred

• Prior experience at a healthcare‑AI, RegTech, AI‑governance, clinical‑evidence, or QMS company.
• Direct relationships with Chief AI Officers, CMIOs, VPs of Regulatory Affairs at health systems, or program leads at FDA, state sandboxes, NHS, or Health Canada.
• Experience designing and selling pilot programs and design‑partner agreements rather than transactional SaaS.
• Technical background — clinical, engineering, data science, biostatistics, regulatory affairs, or law (JD/MPH/RAC welcome).
• Exposure to model risk management or AI assurance in another regulated industry (financial services, defense) translatable to healthcare.

Nice to have

• Published thought leadership (substack, conference talks, peer‑reviewed work) on clinical AI, regulation, or AI governance.
• Experience hiring and managing a small commercial team.
• Existing network across HIMSS, RSNA, AdvaMed, AMIA, CHAI, or major academic medical centers.
• Competitive base salary calibrated to experience and location.
• Performance‑based variable compensation appropriate for a founding commercial hire.
• Meaningful founding‑team equity grant.
• Health, dental, vision; 401(k); flexible PTO; conference and learning budget.

Precoh is an equal opportunity employer. We welcome applicants from all backgrounds and explicitly encourage applications from clinicians, regulators, and operators considering a move into commercial roles.