Director, Safety and PV Systems (Innovation & AI)

Director, Safety and PV Systems (Innovation & AI) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • 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. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities 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 Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.