Merck
Principal Scientist, Signals Strategy & Informatics Lead
- Location
- (Multi-state)Hybrid
- Posted
- Posted today (employer shows the date only)
- Source
- Workday (employer's applicant tracking system)
- Category
- R&D/Science
- Industry
- Pharma/Biotech
Application: Workday — account required, long form — you fill it in on the employer's site.
UNTIL never charges to apply and never asks for payment or personal info on behalf of employers.
Apply kitYour saved details, ready to copy
From the employer's posting
Job Description
We are a global biopharmaceutical leader with a varied portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to inspire our employees as we learn, develop and grow in our careers. We are proud of our over 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
We are seeking a Principal Scientist, Signals Strategy & Informatics Lead to join our Digital Insights (DI) team within the Development Sciences and Clinical Supply (DSCS) Digital Technologies organization (DDT). Digital is the multiplier that will allow DSCS to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is responsible for the invention and application of new digital tools/workflows to support scientists across drug substance development, drug product development and analytical development. We aspire to embed digital technologies into the fabric of DSCS culture to drive transformational impact across the CMC space. In this role, the Principal Scientist will provide business ownership and scientific leadership for Signals, including its strategy, product roadmap, software development life cycle (SDLC), adoption, and sustained value delivery. The role will connect scientific business needs, digital product delivery, and informatics capabilities to ensure Signals is a trusted platform for structured data capture, method and process/product performance monitoring, predictive analytics, and prospective modeling.
The successful candidate will lead Signals as a strategic scientific and digital capability across DSCS and in partnership with our Discovery and Manufacturing organizations. Responsibilities will include defining and executing the Signals strategy; partnering to establishing Signals data governance, prioritization, and releases through the SDLC; partnering with product, technology, scientific, and quality stakeholders; and advancing informatics solutions that convert structured Signals data into actionable insight. In addition to this role being the primary point of contact for Signals business ownership, the role will establish approaches for monitoring analytical methods, assay performance, product & process trending, performance monitoring, identifying trends and emerging risks, and developing prospective models that support more confident and timely scientific decisions. The role demands strong scientific and informatics leadership, technical supervision of Signals adjacent colleagues, organizational influence, product ownership discipline, and the ability to translate business needs into scalable digital capabilities across CMC development.
Primary Responsibilities.
- Champion the vision for a modern, data-rich DSCS by evolving Signals Notebook from an initial data repository platform into an integrated, automated data hub.
- Serve as the business owner and scientific lead for Signals, accountable for capability vision, value delivery, adoption, and alignment with DSCS priorities; coordinate activities with other functional areas utilizing Signals.
- Define and execute the Signals strategy and multi-year roadmap in partnership with Digital Insights, DDT, scientific functions, GxP-facing teams, Quality, and Enterprise Information Technology teams.
- Own the Signals software development life cycle, including demand intake, requirements gathering, prioritization, release planning, testing, deployment, lifecycle management, and continuous improvement.
- Establish transparent governance, decision rights, stage gates, and success measures for Signals enhancements and new use cases.
- Translate scientific and business needs into clear product requirements, user stories, acceptance criteria, and scalable informatics solutions.
- Lead the Signals informatics strategy for the use of structured data across drug substance, drug product, and analytical development workflows.
- Develop and deploy predictive analytics capabilities, such as method performance monitoring and product trending, to identify trends, variability, method performance, emerging risks, and opportunities for intervention.
- Lead prospective modeling initiatives based on structured Signals data to improve prediction, planning, investigations, and scientific decision-making.
- Partner with laboratory scientists, analytical leaders, data scientists, statisticians, software engineers, and digital product teams to design solutions that align with scientific workflows.
- Ensure Signals data and workflows support appropriate data quality, traceability, metadata management, governance, and data reuse for analytics and modeling.
…
Similar live roles
- Director Occupational Toxicology
AstraZeneca · Posted today
- Clinical Study Specialist
Regeneron · Posted today
- Director, Cardiovascular and metabolic diseases, Clinical Pharmacology Modeling and Simulation
GSK · Posted today
- Clinical Study Assistant
Regeneron · Posted today
- Manager, Clinical Study Lead (Oncology)
Regeneron · Posted today
- Core Lab Supervisor
Labcorp · Posted today
Indianapolis IN