Full-Time
AI Product Lead
Updated on 8/1/2026
AlphaLife Sciences
11-50 employees
AI-driven clinical development and regulatory writing
Compensation Overview
$200k - $250k/yr
No H1B Sponsorship
Jersey City, NJ, USA
Hybrid
Hybrid work arrangement in Jersey City.
 Product (1) |
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- The candidate must have at least 8 years of product management experience in B2B SaaS or AI-driven products, including at least 3 years in leadership roles.
- The candidate must have proven experience building and scaling product teams in high-growth environments.
- The candidate must have a strong understanding of artificial intelligence and large language model-powered product development and application in real-world workflows.
- The candidate must be familiar with pharmaceutical, clinical, or regulated industry workflows, or be able to ramp up quickly.
- The candidate must be able to define product strategy and deliver measurable business impact in complex environments.
- The candidate must have strong communication skills for executive-level stakeholders and the ability to operate in ambiguity.
- A bachelor's degree is required.
- Applicants must be authorized to work in the United States without the need for current or future visa sponsorship.
- Define and own the product vision, strategy, and roadmap for artificial intelligence-powered clinical documentation products aligned with company goals.
- Build, lead, and scale a high-performing product management team, including establishing hiring, onboarding, and career development frameworks.
- Define product management best practices and decision-making frameworks across the organization.
- Act as a strategic partner to the chief executive officer on product direction and validate assumptions through customer and market insights.
- Develop expertise in clinical, regulatory, and medical writing workflows, including protocols, clinical study reports, and Investigational New Drug and New Drug Application modules.
- Build relationships with senior leaders in pharmaceutical companies, contract research organizations, regulatory affairs, and medical writing teams.
- Lead market research and customer discovery to identify unmet needs and product opportunities.
- Own the end-to-end product lifecycle from concept to delivery across multiple product lines.
- Define prioritization frameworks balancing customer needs, technical feasibility, regulatory requirements, and business impact.
- Write product requirements for artificial intelligence-powered clinical documentation solutions informed by Food and Drug Administration and International Council for Harmonisation standards.
- Partner with Engineering, Quality Assurance, and cross-functional teams to ensure high-quality execution.
- Define strategy for generative artificial intelligence and large language model applications in medical writing and clinical documentation.
- Evaluate build-versus-buy-versus-partner decisions for artificial intelligence capabilities.
- Define success metrics for artificial intelligence features, ensuring accuracy, compliance, and user value.
- Drive release planning, sprint coordination, and execution quality across product teams.
- Establish and report product key performance indicators to executive leadership.
- Represent the product function in executive and strategic planning discussions.
- An advanced degree is preferred.
- Experience in clinical operations, medical writing, or regulatory affairs within life sciences is preferred.
- Existing relationships with senior leaders at pharmaceutical companies are preferred.
Automates medical writing and regulatory documentation for clinical development through its AuroraPrime platform, using Agentic AI to generate and organize content. It helps speed drug R&D and regulatory submissions across therapeutic areas. It differentiates itself with partnerships including Microsoft as Global AI Content Automation Partner for Life Sciences and programs from Johnson & Johnson Innovation JLABS, Google for Startups, Nvidia Inception, and Veeva AI. The goal is to accelerate drug development and regulatory submissions so patients can access therapies sooner.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Singapore, Singapore
Founded
2020
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Simplify's Take
What believers are saying
- Delivers 90% reduction in first draft time for Clinical Study Reports and Protocols, with up to 70% overall time savings.
- New RMA Usage Dashboard and auto-generated structured CSR synopses double summarization capacity to 10 TFLs.
- Modular LLM framework automates end-to-end creation of CSRs, protocols, and safety narratives while integrating flexibly with enterprise systems.
What critics are saying
- GPT-5 model dependency creates single-vendor lock-in; if performance degrades or licensing changes, authoring quality collapses within 12–18 months.
- Tight coupling with Microsoft Word 365 means any update breaking Add-In compatibility halts first-draft generation for 90% of users in 6–12 months.
- AI hallucinations in Clinical Study Reports are intolerable; a single untraceable error could trigger FDA audit and product recall within 12–24 months.
What makes AlphaLife Sciences unique
- AlphaLife Sciences is purpose-built for regulated pharma R&D, not retrofitted from generic enterprise AI.
- AuroraPrime grounds every output in verified source documents through RAG architecture, keeping medical writers in control.
- Trusted by more than half of the top global pharmaceutical companies for regulatory and medical authoring workflows.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Disability Insurance
Life Insurance
Flexible Work Hours
Company Equity
Professional Development Budget
Company News
Redefining regulatory integrity: key takeaways from AlphaLife Sciences at Microsoft Ignite 2025. Feb 12, 2026 What does regulatory integrity look like in the age of AI? At Microsoft Ignite 2025, AlphaLife Sciences took the stage to explore how intelligent platforms, structured data, and responsible AI are redefining the regulatory landscape - not just improving efficiency, but fundamentally elevating quality, traceability, and trust. The energy in San Francisco this past November was electric. At Microsoft Ignite 2025, the conversation wasn't just about what AI could do in the future - it was about what it is doing right now to transform industries. For the life sciences sector, the stakes have never been higher. With R&D pipelines expanding fourfold since 2001 and the cost of bringing a drug to market continuing to climb, the industry is at a breaking point. AlphaLife Sciences LLC can no longer afford the status quo of manual data transcription and months-long authoring cycles. At AlphaLife Sciences, AlphaLife Sciences LLC believe the answer lies in Agentic AI - intelligent agents that don't just generate text, but understand the rigorous "blueprints" of regulatory science. If you missed its session, "The blueprint for intelligent AI agents backed by PostgreSQL," here is a recap of how AlphaLife Sciences LLC is rewriting the rules of regulatory documentation alongside its partners at Microsoft. The "three hurdles" of pharma AI. During the session, its Founder and CEO, Sharon Chen, took the stage with Microsoft leaders Maxim Lukiyanov and Abe Omorogbe to address the elephant in the room: Why is it so hard to apply GenAI to regulatory documents? It comes down to three specific hurdles: * Massive Data Volume: A single study generates hundreds of thousands of files - from PDFs to XMLs. * Strict Compliance: "Close enough" doesn't count in regulatory affairs. Every claim must be traceable. * Zero Tolerance for Errors: In an industry where patient safety is paramount, AI hallucinations are not an option. As Sharon noted, the complexity of clinical documentation requires more than a chatbot. It requires intelligent agents that understand data structures, regulatory logic, and version control. A database is more than storage - It's knowledge. One of the most widely discussed insights from its presentation was a fundamental shift in how AlphaLife Sciences LLC view infrastructure. Sharon argued that "A database is not just for storage - it is the semantic knowledge foundation for AI". By building its AuroraPrime platform on a robust architecture involving Azure and PostgreSQL, AlphaLife Sciences LLC allow AI agents to do something remarkable: they can "think" relationally. This means the AI doesn't just guess the next word; it retrieves the correct data, verifies the source, and ensures that a number in the text matches the number in the table. From six months to weeks: the real-world impact. AlphaLife Sciences LLC didn't just talk theory; AlphaLife Sciences LLC showed the engine in action. The session featured a demonstration of end-to-end protocol automation that illustrated exactly how these agents work as "digital coworkers". Imagine drafting a Clinical Study Report (CSR) - a process that traditionally consumes up to six months. Its agents can: * Draft and refine sections by pulling directly from a centralized reference pool. * Auto-cite sources, providing a clear audit trail for human reviewers. * Intelligently handle amendments, identifying which sections need to change based on new data. The potential impact? Cutting authoring timelines by half or more, translating to billions in time and cost savings for large pharmaceutical companies. Watch the full session. The era of intelligent cloud technology is here, and it is ready for the enterprise. At AlphaLife Sciences, its goal isn't to replace human expertise but to extend it - creating systems that are structured, compliant, and safe. If you are ready to see the blueprint for the future of regulatory writing, AlphaLife Sciences LLC invite you to watch the full session recording and download the slide deck. Let's build a future where AlphaLife Sciences LLC spend less time on paperwork and more time on patients.
Critically, AlphaLife Sciences LLC has introduced a new "Project Creator" role, allowing designated users to create new Writing Projects directly in the add-in.
AlphaLife Sciences LLC is excited to unveil the latest AuroraPrime RMA release, packed with powerful new enhancements designed to empower clinical operations, medical writing, and regulatory affairs teams like never before.
AlphaLife Sciences actively participated in the Biotech Showcase 2025, held from January 13 to 15 in San Francisco.
AlphaPrime Life Sciences collaborates with LUNAN PHARMACEUTICAL GROUP to empower efficient medical team writing and collaboration.