Director, Regulatory Data & Informatics Transformation

Merck; New Jersey; On-site; USD 190,000 - 260,000; Full time

Job summary

Merck seeks a Director to lead an organization responsible for regulatory data management, informatics and analytics, and enterprise data systems from IND through NDA/BLA submissions and post‑filing activities.

The role centers on delivering trusted regulatory data, scalable analytics, and data-driven decision support across lifecycle stages, with strong collaboration across Regulatory CMC, Quality, Digital, and R&D divisions.

Qualifications

• Bachelor's degree with at least 15 years of experience in analytical development, chemistry, pharmaceutical sciences, informatics, data science, regulatory CMC, or related fields; or Master's with 10+ years or PhD with 7+ years.
• Proven leadership of data management, informatics, analytics, laboratory systems, enterprise data platforms, or digital transformation in a regulated environment.
• Strong people leadership, stakeholder management, and cross-functional influence with a track record of building high-performing teams and delivering business results.

Responsibilities

• Lead an integrated organization supporting regulatory data management, informatics analytics, and enterprise data system capabilities that enable scientific excellence, regulatory compliance, and digital transformation.
• Deliver accurate, traceable, and submission-ready regulatory data across the product lifecycle (IND to post-approval filings).
• Advance scalable analytics, visualization, and self-service data solutions that support proactive product monitoring and data-driven decisions.
• Serve as business owner or representative for enterprise data systems, driving strategy, governance, enhancements, adoption, and business value.
• Translate scientific, regulatory, quality, and business needs into scalable digital capabilities and data solutions.
• Partner across scientific, regulatory, quality, and technology organizations to deliver scalable, sustainable, and compliant solutions.
• Drive standardization, automation, and continuous improvement to enhance data quality and efficiency.
• Ensure solutions are compliant, inspection-ready, scalable, and aligned with enterprise data and digital strategies.

Skills

Academic Presentations

Bioconjugation

Computational Chemistry

Creativity

Data Analysis

High-Throughput Experimentation (HTE)

Organic Synthesis

Professional Networking

Project Leadership

Research Proposal Dev

Education

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Data Science, Statistics, Computer Science, Engineering, or related discipline

Master's degree

Ph.D.

Job description

Merck seeks a Director to lead an organization responsible for regulatory data management, informatics and analytics, and enterprise data systems from IND through NDA/BLA submissions and post‑filing activities.

The role centers on delivering trusted regulatory data, scalable analytics, and data-driven decision support across lifecycle stages, with strong collaboration across Regulatory CMC, Quality, Digital, and R&D divisions.