Assoc Dir Product Management

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

Responsibilities:

• Lead, coach, and develop Product Leads and Product Analysts across protocol digitization, biospecimen/sample management, and AI/agentic orchestration.
• Set objectives, build domain capabilities, and drive process improvement.
• Own domain strategy, vision, and roadmap for USDM/ICH M11 protocol digitization, Digital Data Flow (DDF), and human sample lifecycle.
• Build and manage senior stakeholder relationships (BSPs, Business Process Owners, SMEs, Corporate IT, vendors).
• Chair domain steering/gov forums; drive alignment, consistency, and reuse.
• Own end-to-end domain product portfolio: requirements, testing/UAT, risk-based CSV, and ITIL-aligned release/change/incident processes for audit readiness and compliance.
• Intake and validate domain requirements; manage scope, dependencies, and trade-offs.
• Define human-in-the-loop, multi-agent orchestration and regulated-AI governance aligned to 21 CFR Part 11/Annex 11 and GxP.
• Manage build-vs-buy, RFPs, contracting, vendor performance, and delivery resourcing.
• Ensure digital protocol and Schedule of Activities as system of record with traceable lineage from protocol intent to SDTM/ADaM.
• Direct biospecimen/sample standards, metadata, and integration ecosystem (MDR, EDC, IRT, LIMS/LIS, CTMS, analytics).

This Role Requires:

• Strong command of ICH M11/USDM and CDISC SDTM/ADaM; controlled terminology and standards governance; experience with USDM-aligned tools (e.g., Nurocor) or equivalent MDRs.
• Communication skills to influence senior leaders.
• Clinical human sample workflow knowledge (kit management, barcoding, custody, reconciliation) and lab operating models/integrations (SAP/EDC).
• Experience with technology selection/implementation/operations; LIMS/LIS integrations; vendor governance.
• Experience applying AI/multi-agent systems with human-in-the-loop controls; REST/GraphQL and ETL/ELT on cloud platforms.
• Knowledge of Global Development capabilities/processes; SDLC and ITSM/ITIL; strong project/budget/stakeholder management.
• Preferred: SQL/Python or R for prototyping/validation and regulated MLOps; exposure to TransCelerate DDF and CDISC 360.
• Experience with risk-based CSV and regulated-AI governance aligned to 21 CFR Part 11/Annex 11, GxP, HIPAA/GDPR, RBAC.
• Experience hiring/coaching direct reports; leading end-to-end product launches/shutdowns; strategic/tactical leadership amid ambiguity.