Director, Data Management and Informatics

The Director will lead a business-critical organization responsible for regulatory data management, informatics and analytics, and enterprise data system business ownership. This role enables the delivery of trusted scientific and regulatory data across the product lifecycle – from IND through NDA/BLA submissions, post-filing activities, product monitoring, and inspection readiness- while advancing scalable digital solutions that improve data accessibility, automate manual processes, strengthen compliance, and enable data-driven decision-making. Partnering across Analytical Development, Regulatory CMC, Quality, Digital, our Research & Development Division, and our Manufacturing Division organizations, the Director will align business priorities, deliver sustainable digital capabilities, and build a high-performing team that accelerates scientific innovation and digital transformation, * 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 (from IND, NDA/BLA to post-approval filings).
• Advance scalable analytics, visualization, and self-service data solutions that support proactive product monitoring, operational transparency, accelerate insights, and support 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 that improve efficiency, strengthen compliance, and maximize the value of enterprise data assets.
• 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, traceability, and operational efficiency.
• Ensure solutions are compliant, inspection-ready, scalable, and aligned with enterprise data and digital strategies.

Required

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Data Science, Statistics, Computer Science, Engineering, or related discipline with at least fifteen (15) years of analytical development, chemistry, pharmaceutical sciences, informatics, data science, regulatory CMC, Quality, or a related experience; OR Master’s degree with at least ten (10) years or Ph.D. with at least seven (7) years.
• Proven leadership of data management, informatics, analytics, laboratory systems, enterprise data platforms, or digital transformation initiatives in a regulated environment.
• Strong people leadership, stakeholder management, and cross-functional influence skills with a track record of building high-performing teams and delivering business results.
• Working knowledge of data integrity, regulatory requirements, quality systems, laboratory operations, and enterprise system lifecycle management.
• Strong strategic thinking, business acumen, change leadership, stakeholder engagement, execution, and problem-solving skills, with a track record of delivering measurable business value through people, processes, data, and technology.

Preferred

• Experience in managing diverse teams of scientists, contractors, and cross-functional contributors.
• Experience supporting regulatory submissions and post-filing activities from IND through NDA/BLA.
• Experience applying analytical laboratory expertise to improve scientific data generation, review, and consumption across development, stability, quality, and regulatory workflows.
• Experience serving as a business owner or product owner for enterprise systems, digital products, or data capabilities.
• Knowledge of AI/GenAI, advanced analytics, or emerging digital technologies and their application to scientific and regulatory data workflows.
• Experience delivering trusted, compliant, and inspection-ready scientific and regulatory data that support development, regulatory submissions, and commercial products.
• Demonstrated ability to develop scalable digital capabilities that improve data accessibility, increase automation, strengthen compliance, and enable data-driven decisions., Academic Presentations, Bioconjugation, Computational Chemistry, Creativity, Data Analysis, High-Throughput Experimentation (HTE), Organic Synthesis, Professional Networking, Project Leadership, Research Proposal Development, Scientific Leadership, Scientific Literature Search, Strategic Thinking, Structure Based Drug Design, Synthetic Chemistry

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$173,200.00 - $272,600.00

We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join us in our mission to make a difference., Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.