Senior Business Development Leader
Precoh · United States
- Hybrid
- Contract
- $150,000 / year
- United States
Job highlights
- Drive business development in regulated AI markets.
- Build and own commercial strategy end-to-end.
- Translate complex technical solutions to buyers.
- Develop and manage sales pipeline and team.
- Shape category creation and thought leadership.
About the role
About Precoh
Precoh helps healthcare and life sciences organizations transition from AI experimentation to effective execution. Our expertise lies in creating secure data solutions, governed workflows, and actionable AI strategies for regulated environments. As both a consultancy and a platform company, Precoh specializes in building clinical AI data readiness and operationalizing it. We collaborate with health systems, CROs, payers, and biopharma innovators to implement AI solutions that adhere to FDA regulations and HIPAA compliance. Our mission is to enable measurable progress in regulated industries through trusted AI execution.
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.
- 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.
Role Description
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.
Qualifications
- Bachelor’s degree in Business, Healthcare, or related fields; advanced degree is a plus
- Track record of successful business development and leadership in regulated industries
- 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.
- Understanding of healthcare and life sciences industry regulations, including FDA and HIPAA compliance (preferred)
- 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.
Compensation & Benefits
- 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.
How to Apply
Send the following to apply:
- Resume or CV.
- A short note (≤ 400 words) on the most complex regulated-market deal you have personally closed - buyer, problem, what you built, what you would do differently.
- Optional: A buyer or category you think Precoh is underweighting, and why.
We read every application. We respond to every candidate who completes #2.
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.
Key skills/competency
- Business Development
- Commercial Strategy
- Go-to-Market (GTM)
- Regulated Industries
- Healthcare AI
- Regulatory Affairs
- Enterprise Sales
- Pipeline Management
- Deal Negotiation
- Thought Leadership
Skills & topics
- Business Development
- Commercial Strategy
- Go-to-Market
- Regulated Industries
- Healthcare AI
- AI Governance
- Enterprise Sales
- Sales Leadership
- Pipeline Management
- Deal Negotiation
- FDA Regulations
- HIPAA Compliance
- SaMD
- EU MDR
- Salesforce
- CRM
- Forecasting
- Pilot Programs
- Design Partners
- Thought Leadership
- Atlanta
- Remote
- Healthcare Technology
- Life Sciences
- RegTech
- Clinical AI
- Model Risk Management
How to get hired
- Tailor your resume: Highlight experience in regulated industries, business development, and complex enterprise deals. Emphasize your GTM strategy and commercial leadership skills.
- Craft a compelling application note: Detail your most complex regulated-market deal, showcasing your problem-solving and deal-closing abilities.
- Prepare for technical discovery: Familiarize yourself with regulatory AI vocabulary and pathways (SaMD, FDA, EU MDR, etc.).
- Showcase founder-mode operation: Demonstrate your ability to build from scratch, including CRM, decks, and demos.
- Network strategically: Leverage existing relationships in healthcare AI, RegTech, or regulatory affairs for an advantage.
Technical preparation
Understand FDA SaMD risk classes and pathways.,Familiarize with EU MDR and IMDRF guidelines.,Learn GMLP, AI assurance frameworks (NIST, ISO).,Study clinical validation and model risk management.
Behavioral questions
Describe building a pipeline from zero.,How do you handle skeptical, technical buyers?,Detail managing multi-stakeholder enterprise deals.,How do you translate regulatory needs into sales?
Frequently asked questions
- What specific regulatory AI knowledge is crucial for a Senior Business Development Leader at Precoh?
- For this Senior Business Development Leader role at Precoh, a deep understanding of regulated-AI vocabulary is essential. This includes familiarity with SaMD, FDA premarket pathways (like 510(k) and De Novo), EU MDR classifications, IMDRF guidelines, clinical validation processes, model risk management, AI governance, bias/fairness considerations, and post-market monitoring. Experience with AI assurance frameworks such as NIST AI RMF and ISO/IEC 42001 is also highly valued.
- How can I demonstrate my 'founder-mode operator' capabilities in my application for the Senior Business Development Leader position at Precoh?
- To showcase your 'founder-mode operator' capabilities for the Senior Business Development Leader role at Precoh, highlight instances where you independently built a sales pipeline from scratch, developed sales decks, conducted product demonstrations, and managed the entire sales cycle without significant oversight. Emphasize your proactivity, resourcefulness, and ability to establish and execute commercial operations from the ground up.
- What is the expected experience level for a Senior Business Development Leader at Precoh, particularly in deal-making?
- Precoh seeks a Senior Business Development Leader with at least 8 years in business development, commercial strategy, or GTM leadership, including a minimum of 3 years selling technical products or advisory services into healthcare, life sciences, or another regulated industry. A proven track record of closing large, complex enterprise deals involving multiple stakeholders across procurement, security, legal, and clinical departments is critical.
- Does Precoh consider remote candidates for the Senior Business Development Leader role?
- Yes, Precoh considers remote candidates for the Senior Business Development Leader position, especially for exceptional individuals. However, the role is based in Atlanta, and candidates may be expected to spend material time in the office. Exceptional remote candidates will be given full consideration.
- What is the application process for the Senior Business Development Leader role at Precoh?
- To apply for the Senior Business Development Leader role at Precoh, you need to submit your resume or CV along with a short note (under 400 words) detailing the most complex regulated-market deal you've personally closed. Optionally, you can suggest a buyer or category Precoh might be underweighting. Precoh reads every application and responds to candidates who complete the specified note.