Product Director, Regulated AI & Protocol Digitization

Scorpion Therapeutics; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics in New Jersey is seeking a seasoned Domain Lead to direct protocol digitization, biospecimen management, and AI orchestration. You will guide product teams, set objectives, and drive process improvements across the data flow and lifecycle to ensure compliance.

You will own the domain strategy and roadmap, manage end-to-end product lifecycles from requirements to release, and maintain audit readiness with USDM/ICH M11, CDISC standards, and regulated-AI governance.

Qualifications

• Strong command of ICH M11/USDM and CDISC SDTM/ADaM governance.
• Experience with AI/multi-agent systems with human-in-the-loop controls.
• Experience with LIMS/LIS, EDC integrations and vendor governance.
• Knowledge of 21 CFR Part 11/Annex 11, GxP, HIPAA/GDPR.
• Ability to define domain requirements and manage scope and trade-offs.
• Proficiency in SQL/Python or R for prototyping.

Responsibilities

• Lead and develop Product Leads and Analysts across protocol digitization and AI orchestration.
• Own domain strategy, objectives, and roadmap; drive process improvements.
• Own end-to-end domain product portfolio including requirements, testing, risk-based CSV, and ITIL-aligned processes.
• Build senior stakeholder relationships (BSPs, SMEs, IT, vendors).
• Chair domain forums; drive alignment, reuse, and governance.
• Oversee intake, scope, dependencies, and trade-offs for domain work.
• Define human-in-the-loop, multi-agent orchestration and regulated-AI governance.
• Manage build-vs-buy, RFPs, contracting, and vendor performance.
• Ensure system of record with traceable lineage from protocol to SDTM/ADaM.
• Direct biospecimen standards, metadata, and integration ecosystem (MDR, EDC, IRT, LIMS/LIS, CTMS).

Skills

ICH M11 governance

CDISC SDTM/ADaM

AI/multi-agent systems

Human-in-the-loop controls

Domain strategy & roadmap

Vendor governance

LIMS/LIS integration

EDC/SAP integration

REST/GraphQL & ETL/ELT

SQL/Python or R prototyping

Project/budget/stakeholder mgmt

Tools

Nurocor MDRs

LIMS/LIS tools

CTMS/SAP/EDC

CDISC 360

Job description

Scorpion Therapeutics in New Jersey is seeking a seasoned Domain Lead to direct protocol digitization, biospecimen management, and AI orchestration. You will guide product teams, set objectives, and drive process improvements across the data flow and lifecycle to ensure compliance.

You will own the domain strategy and roadmap, manage end-to-end product lifecycles from requirements to release, and maintain audit readiness with USDM/ICH M11, CDISC standards, and regulated-AI governance.