Director, AI (Artificial Intelligence) (R&D)

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Full Time Management Plymouth Meeting Office, Plymouth Meeting, PA, US

30+ days ago Requisition ID: 1580

Harmony Biosciences is recruiting for a Director, A I (Artificial Intelligence) in our Plymouth Meeting location . The R&D & AI business Technology Partner bridges R&D and technology to identify, prioritize and operationalize processes, technology and AI needs across Clinical, Data Management, Regulatory, Safety and Quality pillars within Harmony Biosciences. This role will work within the IT team to advise and drive out-of-box AI solutions and/ or any Agentic AI use cases including AI technologies/ solutions to accelerate drug discovery, reduce cycle times and ensure safe, compliant deployment across regulated biopharma R&D workflows. The role leads cross‑functional collaborations (R&D, IT, legal, regulatory and external partners), manages vendor/build decisions and drives AI governance, data readiness and model lifecycle practices required for validated, explainable and auditable outcomes. The R&D & AI Business Technology Partner role is a hands‑on subject matter expert responsible for shaping and enabling Data, AI, and technology-driven business solutions across the pharmaceutical enterprise, with a good knowledge of both the processes and the solutions.

Responsibilities include but are not limited to:

R&D Process Optimization & Transformation

• Serve as a trusted advisor to R&D leadership (Clinical, Regulatory, Safety, Medical Affairs) on technology process improvement and digital enablement.
• Lead end-to-end technology process assessments and redesign initiatives across:
  • Clinical trial lifecycle (study start-up, execution, closeout)
  • Regulatory submission and document management
  • Pharmacovigilance and safety case processing
  • Medical information and insights generation
• Identify inefficiencies and implement standardized, scalable, and compliant technology process models .
• Establish KPIs, process metrics, and continuous improvement frameworks .
• Identify, prioritize, and deliver AI and automation use cases embedded within R&D workflows (ex. protocol optimization and trial design analytics, Patient recruitment and site selection models, Automated document authoring (e.g., CSR, protocols, regulatory dossiers), Signal detection and case processing in pharmacovigilance, Scientific literature mining and medical insights generation
• Drive the adoption of GenAI copilots, NLP solutions, and predictive analytics within R&D processes.
• Partner with Data Science and Engineering teams to operationalize AI (MLOps, model lifecycle management) .

Business Partnership & Value Realization

• Act as the primary technology business partner between R&D and IT/Data & AI teams .
• Translate business challenges into clear process improvement and AI use cases , supported by quantified business value.
• Build and maintain a multi-year R&D technology process and AI roadmap aligned with portfolio and pipeline priorities.
• Define and track value realization metrics (cycle time reduction, cost savings, quality improvements, compliance outcomes).

Engagement Management Leadership & Delivery

• Lead cross-functional initiatives delivering process transformation and AI-enabled solutions .
• Ensure alignment with scope, timelines, budgets, and quality expectations .
• Manage external vendors, technology partners, and consulting resources.
• Drive agile delivery models for iterative deployment and scaling of solutions.
• Ensure all process changes and AI implementations comply with GxP, 21 CFR Part 11, and global regulatory requirements, Data integrity and audit trail standards as well as Privacy regulations (HIPAA, GDPR where applicable)

Qualifications:

• Bachelor’s degree in Business, Information Systems, Life Sciences, Data/Analytics, or related field required
• 10+ years of experience in Pharma / Life Sciences within an IT scope required
• 5+ years in the following is required:
  • Business technology / IT partnership
  • Commercial technology, Analytics / BI / reporting
  • Hands‑on experience with Veeva, preferably in areas such as:
    • Veeva Vault and CRM
    • Veeva commercial data warehousing and reporting
• 5+ years defining or supporting analytics, AI, automation, or decision‑support solutions
  • Uses case development
  • Agentic AI
• AI/ML, GenAI, NLP, and automation technologies
• Strong understanding of pharma business processes, especially in:
  • R&D and Commercial
  • How AI relates to these processes
• Proven ability to work across business, IT, data, compliance, and vendor teams
• Familiarity with:
  • CRM analytics and customer engagement analytics
  • AI/ML use cases in commercial and medical functions
  • Intelligent search, summarization, and copilots
  • Data governance, master data, and data quality frameworks
• Knowledge of:
  • Responsible AI principles
  • CSV/CSA and validation expectations in regulated environments
  • Change management and user adoption best practices

Physical demands and work environment: