Director, Safety and PV Systems – Innovation, AI

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🤖 Artificial Intelligence

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Owns the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics—balancing speed, compliance, and value • Leads cross-functional execution with internal teams and external vendors/SIs; establishes governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5) • Chairs innovation councils with customers and partners; converts problem statements into pilots/PoCs with clear success criteria and scales proven patterns into offering • Serves as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses • Publishes points of view, presents at conferences/webinars, and briefs executives on the PV tech landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics) • Leads live demos, workshops and innovation sessions • Manages a small, senior team: mentors; drives portfolio planning, resourcing, budgets, and benefits realization • Embeds risk-based quality, privacy, and security by design; partners closely with QA/Compliance and Data Privacy to ensure all solutions meet regulatory, quality, and data privacy requirements • Design and build minimally viable AI/ML prototypes and proof of concepts (POCs) including LLM-based agents and automation solutions, using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms • Develop or utilize connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware) • Rapidly translate ideas to address PV Operational challenges into working demos to validate feasibility and business value • Partner with engineering teams to transition POCs into scalable solutions • Design and optimize prompt frameworks for PV use cases and establish prompt and accuracy governance • Continuously refine AI outputs through testing, feedback loops, and performance • Support AI model validation, monitoring, explainability, and risk management • Lead and mentor AI/PV specialists

🎯 Requirements

• Owns the roadmap and delivery of end-to-end SPVG technology solutions across case intake/processing, signal, aggregate reporting, submissions, QPPV oversight, literature, and safety analytics • Leads cross-functional execution with internal teams and external vendors/SIs; establishes governance, SLAs/KPIs, and validated deployments (CSV, 21 CFR Part 11, EU Annex 11, GAMP 5) • Chairs innovation councils with customers and partners; converts problem statements into pilots/PoCs with clear success criteria and scales proven patterns into offering • Serves as solution lead on RFIs/RFPs: reference architectures, delivery models, scope/estimation, commercial constructs, and oral/bid defenses • Publishes points of view, presents at conferences/webinars, and briefs executives on the PV tech landscape (AI/NLP/RPA, data platforms, cloud, real-world data, advanced analytics) • Leads live demos, workshops and innovation sessions • Manages a small, senior team: mentors; drives portfolio planning, resourcing, budgets, and benefits realization • Embeds risk-based quality, privacy, and security by design; partners closely with QA/Compliance and Data Privacy to ensure all solutions meet regulatory, quality, and data privacy requirements • Design and build minimally viable AI/ML prototypes and proof of concepts (POCs) including LLM-based agents and automation solutions, using tools such as OpenAI, Azure OpenAI, Microsoft Copilot, and related platforms • Develop or utilize connectors and integrations between AI tools and PV systems (e.g., APIs, data pipelines, middleware) • Rapidly translate ideas to address PV Operational challenges into working demos to validate feasibility and business value • Partner with engineering teams to transition POCs into scalable solutions • Design and optimize prompt frameworks for PV use cases and establish prompt and accuracy governance • Continuously refine AI outputs through testing, feedback loops, and performance • Support AI model validation, monitoring, explainability, and risk management • Lead and mentor AI/PV specialists

🏖️ Benefits

• We are passionate about developing our people, through career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Committed to building an inclusive culture – where you can authentically be yourself